[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"art\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:art":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,42,80,122,148,174,208,235,260,289,318,348,377],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100487333","phase-3-aspirin-for-the-prevention-of-preeclampsia-and-pregnancy-outcomes-after-assisted-reproductive-technology-100487333",false,"NCT05625724","Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes After Assisted Reproductive Technology","Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes in Nulliparous Women After Assisted Reproductive Technology. APPART","APPART","Inclusion Criteria:\n\n* Nulliparous women aged 18 years or more\n* Pregnancy following ART, including in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), oocyte donation or intrauterine insemination with sperm donor\n* Singleton pregnancy\n* Evolutive pregnancy between 9 and 14 weeks of gestation\n* Women affiliated to a French Social Security Insurance or equivalent social protection\n* Written informed consent\n\nExclusion Criteria:\n\n* Major fetal abnormality\n* Regular treatment with aspirin (including antiphospholipid syndrome)\n* Aspirin contraindications (allergy, von Willebrand disease, peptic ulceration, hemophilia)\n* Women protected by law.\n* Women included in another interventional study.","FEMALE","18 Years",{"count":20,"type":21},1164,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study seeks to validate the hypothesis that nulliparous pregnant women after Assisted Reproductive Technology (ART) are at high risk of preeclampsia and perinatal complications and represent a subgroup for which aspirin prophylaxis during pregnancy may be effective in the prevention of preterm preeclampsia and other perinatal adverse outcomes.",[27,28],"ART","Pre-Eclampsia","RECRUITING","2026-05-04",{"date":32,"type":33},"2026-05-07","ACTUAL",{"date":35,"type":33},"2023-08-02",{"date":37,"type":21},"2029-05",{"name":39,"class":40},"University Hospital, Toulouse","OTHER",21,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100623403","standardization-of-variable-conditions-of-embryo-transfer-into-the-uterine-cavity-in-the-procedure-of-medically-assisted-procreation-in-humans-100623403","NCT07396181","Standardization of Variable Conditions of Embryo Transfer Into the Uterine Cavity in the Procedure of Medically Assisted Procreation in Humans","A Randomized, Prospective, Single-center, Controlled, Single-blind Study to Evaluate the Impact of Standardization of Variable Embryo Transfer Conditions in a Medically Assisted Procreation Procedure in Humans on the Effectiveness of the Procedure, by Using: Standardization of Culture Conditions and Selection of Embryo for Transfer Through the Use of an Incubator With a Time-lapse Observation System and AI, an Embryopass-electronically Controlled Device for Controlled ET, and the Embryocase Device Maintaining Optimal Environmental Conditions for the Embryo Outside the Incubator During ET Time","EFECT","Inclusion Criteria:\n\n* The patient and her partner gave written, informed consent to participate in the clinical trial.\n* The patient underwent a medically assisted procreation procedure using IVF or ICSI in accordance with the applicable law, did not have a fresh transfer, has all frozen embryos in the blastocyst stage, of which at least 1 is of good quality\n* You and your partner are not currently taking part in or have not participated in any other clinical trial in the last 6 months.\n* The patient's age on the day of screening ranges from ≥18 to ≤38 years.\n* The patient's BMI on the day of screening ranges from ≥18 to \\\u003C 30.\n* Both partners have normal infectious tests performed 6 months before ET and bacteriological tests performed one month before ET.\n* The patient has had IVF or ICSI embryo culture performed in an incubator with a Time Lapse monitoring system and an Artificial Intelligence system (or if not, the embryo will be placed in the EmbryoScope after thawing) and has not had a fresh transfer (all embryos after stimulation and puncture have been frozen), and after thawing she has at least 1 good quality blastocyst evaluated before freezing by an embryologist as a good quality blastocyst or bl class. 3.2.2. The embryos have also been evaluated by AI prior to freezing and will be thawed in the future in order of the highest AI-confirmed rating.\n* The patient has a normal uterus and endometrium at least 7 mm on ET.\n* The patient must be prepared for cryotransfer in the ovulatory cycle with natural or induced letrozole, and after ovulation in the current cycle, take a progesterone preparation at the doses specified above for luteal phase supplementation.\n* On the day of transfer (5th day after ovulation), the patient must have at least one thawed, developed embryo of good quality - pre-frozen blastocyst 3.2.2 thawed according to the highest AI rating.\n* The patient must be qualified by the doctor for the procedure embryo transfer on day 5 after ovulation.\n* Embryo transfer was performed without general anesthesia or other procedures and\u002For additional antispasmodic drugs prior to transfer (e.g. oxytocin antagonist) with the exception of routine preparation (drotaverine 1 table and 20 mg p.o. per hour prior to transfer).\n\nExclusion Criteria:\n\n* Failure to meet the inclusion criteria.\n* The patient was found to have abnormalities in the anatomical structure of the uterus and reproductive tract, which, according to the researcher, could reduce the chances of getting pregnant.\n* The patient was diagnosed with endometrial polyp(s).\n* The patient was diagnosed with submucosal or intramural uterine fibroids.\n* The patient was diagnosed with fallopian tube hydromas.\n* The patient was diagnosed with ≥3 endometriosis.\n* The patient or her partner is a carrier of a genetic defect that may have an impact on lowering fertility.\n* The patient or her partner is currently or has been undergoing cancer treatment in the past, which may have had a negative impact on fertility.\n* The patient has had 1 unsuccessful embryo transfer in the past, which means no clinical pregnancy.\n* During the trial transfer in the preceding cycle, difficulties in entering the uterine cavity (the so-called difficult transfer) were found or if the patient had had an embryo transfer in the past and it was described as difficult, even if she became pregnant as a result.\n* Embryos are formed from eggs after PBB (polar body biopsy) of oocytes have been examined or have undergone genetic testing of embryos.\n* The embryos were formed from oocytes after cryopreservation.\n* Semen was obtained for a procedure other than normal ejaculation (retrograde bladder ejaculation, epididymis biopsy, testicular biopsy, M-TESE).\n* The patient did not take progesterone for luteal phase supplementation.\n* Inability to perform embryo transfer on day 5 after ovulation due to medical or random reasons.\n* The patient has indications for general anesthesia or pre-transfer antispasmodic procedure\u002Fmedication (oxytocin receptor antagonist other than Drotaverine, or others that may affect implantation (intralipid, neupogen, and other significant in the investigator's judgment).\n* The patient is to have an incision made in the AH areola before the ET procedure.\n* The patient wants to have Embryoglue used for transfer.\n* The patient takes heparin, Clexane, Acesan, Relanium drugs on and after embryo transfer.","38 Years",{"count":52,"type":21},200,[54],"NA","The EFECT study is a clinical trial designed to determine whether improving the consistency of embryo transfer procedures can increase pregnancy success in patients undergoing frozen embryo transfer (cryoET). While laboratory techniques for fertilization, embryo culture, and selection have advanced significantly, the process of transferring embryos to the uterus remains variable and depends on small procedural differences, such as temperature changes, mechanical forces, timing, and individual operator techniques. These variations may affect embryo survival and implantation, ultimately influencing pregnancy outcomes.\n\nThis study tests whether using specialized devices to standardize key aspects of embryo transfer-specifically temperature stability during transport and controlled, precise embryo aspiration and expulsion speed, optimal fluid volume, programmed injection time, elimination of pressure fluctuations and plunger backflow, prevention of embryo re-aspiration and detection of transfer catherer oclusion-can improve pregnancy rates. All embryos in the study are cultured using time-lapse monitoring and selected using artificial intelligence-supported grading, ensuring uniform quality for all participants. The study compares standard manual embryo transfer with transfer using one or both of the devices: Embryocase, which maintains a stable temperature during transport, and Embryopass, which standardizes the procedure and eliminates human factor.\n\nA total of 160 participants are randomly assigned to one of four groups: manual transfer without device support, manual transfer with Embryocase, transfer with Embryopass, or transfer with both devices. Participants and outcome assessors are blinded to group assignment, while the staff performing the transfer are aware due to the nature of the devices. All participants receive standard luteal phase support with progesterone following routine clinical practice.\n\nThe study's main goal is to evaluate whether these procedural improvements lead to higher rates of biochemical pregnancy (positive pregnancy test) and clinical pregnancy (confirmed by ultrasound). Secondary outcomes include implantation rate, live birth rate, device safety, and ease of use as reported by staff. Pregnancy outcomes, including delivery, pregnancy loss, or ectopic pregnancy, are followed until the end of pregnancy.\n\nBy investigating the impact of procedural standardization, this study aims to determine whether technological improvements during embryo transfer can increase the effectiveness of assisted reproductive treatments. If successful, the results could support the broader adoption of standardized, device-assisted embryo transfer protocols in fertility clinics, helping more patients achieve successful pregnancies.",[57,58,27],"Infertility (IVF Patients)","Infertility",[60,61,62,63,64,65,66,67,68,69,58],"ET","cryo-ET","AI","Embryopass","Embryocase","embryo transfer","device","standardization","efect","controlled","2026-04-08",{"date":72,"type":33},"2026-04-13",{"date":74,"type":33},"2026-01-01",{"date":76,"type":21},"2027-10",{"name":78,"class":40},"Przychodnia Lekarska nOvum Katarzyna Kozioł, Piotr Lewandowski sp.k.",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":107,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"100613200","prior-study-pre-eclampsia-risk-in-oocyte-recipients-100613200","NCT07263490","PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients)","PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients) - Investigating Matching, Biomarkers and Outcomes.","PRIOR","Inclusion Criteria:\n\n* Age \\> 18 years\n* BMI \\\u003C 35 kg\u002Fm2\n* Normal wet smear within the past three years\n* Both nulli- and multiparous\n* Singletons and multiple gestations\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* BMI \\> 35 kg\u002Fm2\n* HIV\u002F hepatitis\n* Essential hypertension\n* Chronic kidney disease\n* Undiagnosed vaginal bleeding\n* Uterine malformations\n* Persisting ovarian cysts\n* Tumors in hypothalamus, pituitary, thyroid, or adrenal glands.\n* Previous breast cancer\n* Known BRCA 1 or 2 gene\n* Unregulated thyroid disease\n* Cardiovascular disease\n* Breast feeding\n* Present or previous chemotherapy\u002Fradiation therapy\n* Present or previous malignant disease\n* Smoking\n* Alcohol\u002Fdrug abuse",{"count":89,"type":21},462,"OBSERVATIONAL","The aim of this prospective observational cohort study is to investigate the pathophysiological mechanisms behind and risk of pre-eclampsia in women pregnant after fertility treatment with oocyte donation. The participants are included in of of two cohorts. One includes women pregnant after oocyte donation whereas the other includes women pregnant after IVF treatment with autologous oocytes.\n\nParticipants will be followed throughout pregnancy with blood samples, blood pressure, clinical controls and ultrasound examinations. Clinical outcomes will be registered post-partum.",[93,94,95,96,97,98,27,99,100,101,102,103,104,105,106],"Pre-eclampsia","Oocyte Donation","Pre-Eclampsia; Complicating Pregnancy","Pre-Eclampsia; Mild","Pre-Eclampsia, Severe","Pre-eclampsia or Eclampsia With Pre-existing Hypertension","Neonatal Morbidity","Neonatal Mortality","Placental Abruption","Gestational Diabetes","Preterm Labor","Post-partum Hemorrhage (PPH)","Intrauterine Growth Restriction (IUGR)","Hypertensive Disorders of Pregnancy",[93,108,27,109,110,111,112],"Preeclampsia","Gestational hypertension","Oocyte donation","Egg donation","Gamete donation","2026-04-07",{"date":72,"type":33},{"date":116,"type":33},"2024-10-21",{"date":118,"type":21},"2028-06-01",{"name":120,"class":40},"Copenhagen University Hospital, Hvidovre",6,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":129,"sex":130,"minAge":18,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":147},"100560739","automation-of-the-in-vitro-fertilization-laboratory-100560739","NCT06581068","Automation of the In Vitro Fertilization Laboratory","Automation of the In Vitro Fertilization Laboratory: A Validation Study","Inclusion Criteria:\n\n* Informed consent signed by the patients before treatment.\n* Medical indication to perform assisted reproductive technology.\n* Body mass index between 20 and 29 kg\u002Fm2 (female participants only).\n* For women with indication of utilizing autologous eggs:\n\n  * Anti-Müllerian Hormone (AMH) value of at least 1.5 ng\u002FmL.\n  * 18 - 39 years of age.\n* For women utilizing donor eggs (egg donor age 18-28 years):\n\n  * 18 - 45 years of age.\n\nExclusion Criteria:\n\n* Patients diagnosed with recurrent pregnancy loss.\n* Inaccessible ovaries for puncture.\n* History of total or partial fertilization failure in a previous fertility treatment.\n* History of repeated implantation failure defined as three previous unsuccessful embryo transfers.\n* Uterine factors (e.g. fibroids, uterine surgeries, Müllerian malformations) at the discretion of the medical team and based on its impact on success and\u002For risk to the patient or the pregnancy may compromise treatment prognosis).\n* Untreated hydrosalpinx\n* Severe endometriosis III, IV, presence of endometriomas and\u002For history of endometrioma resection.\n* Polycystic ovarian syndrome.\n* Patients with any of the following severe male factor infertility:\n\n  * Sperm concentrations less than 5 million per mL\n  * Progressive motility less than 5%\n  * Others (e.g, globozoospermia and seminal infections) at the discretion of the medical team and based on its impact on success.\n  * Surgically retrieved sperm (TESE, MESA, PESA)\n* Pre-existing conditions compromising reproductive (e.g., thrombophilia, chronic degenerative and autoimmune diseases, uncontrolled hormonal disorders).\n* Any other case of abnormalities that could compromise success rates according to the criteria of clinical personnel in charge.\n* Inability to adhere to the medical protocols and\u002For schedules for personal reasons.\n* Intercurrent medical disorder",true,"ALL","45 Years",{"count":133,"type":21},150,[54],"Enrolled patients will undergo an Assisted Reproductive technology (ART) treatment using intracytoplasmic sperm injection (ICSI, the direct injection of a single sperm cell into an oocyte) as the method of insemination. In this prospective cohort study, patients' sperm, eggs, and embryos will be processed using an automated system called AURA (Conceivable Life Sciences), which consists of five subsystems. Specifically, sperm samples will be prepared for fertilization using the subsystem C:SPERM. Cumulus-oocyte complexes (COCs) containing the oocytes will be isolated from follicular fluid using the subsystem C:EGG. One out of every four COCs will be removed from the AURA system at random and processed according to the local treatment clinic's standard operating procedure. All other COCs will continue automated procedures and will be denuded, fertilized, incubated, and vitrified using the AURA subsystems C:EGG. C:ICSI, C:CULTURE and C:VIT, respectively. All automated procedures will be conducted under the supervision of a laboratory manager, who can intervene, address any potential anomalies, and override any steps undertaken by the automated AURA system. The study aims to deliver a descriptive evaluation of the AURA system, including assessing the device's performance, defined by its level of automation, efficiency, and throughput. As a secondary objective, the study aims to characterize the clinical performance of each of AURA's subsystems and correlate this performance against pre-established benchmarks in a non-inferiority statistical analysis. Finally, the study seeks to collect technical data related to AURA's hardware and software operation.",[58,27],"2026-03-16",{"date":139,"type":33},"2026-03-18",{"date":141,"type":33},"2024-12-03",{"date":143,"type":21},"2027-02",{"name":145,"class":146},"Conceivable Life Sciences","INDUSTRY",2,{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":129,"sex":130,"minAge":18,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":79},"100382129","use-of-artificial-intelligence-for-clinical-assessment-of-assisted-reproductive-techniques-and-ivf-outcomes-100382129","NCT04255615","Use of Artificial Intelligence for Clinical Assessment of Assisted Reproductive Techniques and IVF Outcomes","The Use of Artificial Intelligence for Clinical Assessment of Assisted Reproductive Techniques and IVF Outcomes","AI in ART","Inclusion Criteria:\n\n* All patients undergoing ovarian stimulation (including OI and IVF cycles)\n* Treatment for fresh embryo transfer and cryopreservation of oocytes or embryos upfront\n* Healthy male partners of the female subjects who agree to be part of the study.\n\nExclusion Criteria:\n\n* None","89 Years",{"count":158,"type":21},4000,[54],"The use of machine learning techniques using an artificial intelligence tool is proposed to analyze clinical data to predict best possible IVF\u002FART outcomes. This tool has been utilized to accurately predict embryo quality here at Cornell. Utilizing this tool to assess objective clinical findings and predict outcomes of assisted reproductive techniques is sought, with the ultimate goal of an automated tool to reduce implicit physician bias. Within this goal, using this tool to objectively and accurately assess baseline ovarian reserve at the start of an ART cycle is proposed, using 3D sonography to image the ovary and artificial intelligence tool to objectively identify baseline antral follicle counts.",[58,162,27],"in Vitro Fertilization (IVF)",[164],"Artificial Intelligence","2025-12-17",{"date":167,"type":33},"2025-12-24",{"date":169,"type":33},"2020-02-12",{"date":171,"type":21},"2029-09-30",{"name":173,"class":40},"Weill Medical College of Cornell University",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":130,"minAge":181,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":185,"conditions":186,"keywords":192,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":79},"100614389","enhancing-management-algorithms-for-children-conceived-via-assisted-reproductive-technologies-100614389","NCT07278960","Enhancing Management Algorithms for Children Conceived Via Assisted Reproductive Technologies","Enhancing Algorithms for the Management of Children Conceived by Assisted Reproductive Technologies Based on a Comprehensive Assessment of the Impact of Modern Methods of Conception on Their Health Status","Inclusion Criteria:\n\nFor children:\n\n* Born as a result of an ART program (IVF, ICSI, FET, or Fresh-ET).\n* Age at the time of assessment: from birth up to 36 months.\n* Availability of complete perinatal and medical documentation, including ART cycle characteristics and neonatal outcomes.\n* Informed consent provided by parents or legal guardians for participation in the study and for biological sample collection (where applicable).\n\nFor mothers:\n\n* History of pregnancy achieved through ART within the territory of Kazakhstan.\n* Availability of data on pharmacological treatment before and during pregnancy (e.g., hormonal therapy, antithyroid drugs, vitamins, micronutrients).\n* Willingness to provide anamnestic and perinatal information, and consent for access to medical records.\n\nFor fathers (in ICSI subgroup):\n\n* Documented infertility factor necessitating ICSI.\n* Agreement to provide relevant medical history and participate in comparative analyses (e.g., endocrine or reproductive parameters of father-son pairs).","0 Months","3 Years",{"count":184,"type":21},300,"Research Methods and Ethical Issues\n\n1. Main Scientific Questions and Hypotheses of the Project The primary objective of this project is to investigate the impact of advanced ART methods on the health status of children. The central scientific questions being addressed include: What are the consequences of ICSI and FET on the physical, cognitive, and reproductive health of children? The underlying hypothesis posits that children conceived by advanced ART methods may present with health indicators that deviate from the established norms.\n2. Description of the Experiments\n\nResearch Methods:\n\nTo achieve the goals of the study, the following stages are anticipated:\n\n1. Retrospective Analysis of Anamnestic Data:\n\n   This stage involves studying the relationship between the physical status and morbidity structure of 300 children under the age of three, who were conceived by advanced ART methods. Additionally, the medical history of their mothers regarding the use of various medications during pregnancy-such as estrogen, progesterone, thyroid hormones, antithyroid hormones, vitamins, microelements, and aspirin-will be examined. To facilitate this analysis, individual registration cards will be developed, approved by the ethics committee, and ratified by the Academic Council. The data will be submitted using Google Forms, followed by the inclusion of copyright information into the state register.\n2. Evaluation of Anthropometric Data:\n\n   This stage will assess the anthropometric data of 300 children under three years of age, focusing on those born after FET or fresh embryo transfer (Fresh-ET). Measurements will include weight, height, and head and chest circumference at the time of examination. Measurements for children under one year will utilize scales with a pan balance, a horizontal stadiometer, and a measuring tape. For children over one year, floor electronic scales, a vertical stadiometer, and a centimeter tape will be employed. Birth anthropometric data will be sourced retrospectively, while the WHO Child Growth Standards will be utilized to evaluate weight, height, head, and chest circumference relative to age and gender.\n3. Study of Psychomotor Development:\n\n   The psychomotor development of the 300 children under three years of age conceived via IVF or ICSI in fresh or frozen cycles will be assessed. This evaluation will employ standardized instruments such as the R. Griffiths Mental Development Scale and Denver Developmental Screening Tests. For children under one year, neurosonography will be conducted to assess brain structures, and retrospective results for children over one year of age will be extracted from medical records.\n\n   The assessment aims to determine the functions of the nervous system utilizing the aforementioned standardized scales, focusing on various developmental parameters, including motor skills, social adaptation, communication abilities, and play skills. Scores will be compiled to ascertain overall developmental levels. The Denver II developmental screening test is specifically designed to assess children from birth to six years of age. It enhances diagnostic capabilities and evaluates several critical parameters, including: 1) personal and social characteristics, which examine the child's interactions with others and their ability to meet personal needs; 2) the development of gross and fine motor skills; 3) the development of both motor and sensory speech; and 4) an assessment of the child's behavior during the evaluation process.\n\n   In cases where children are identified as being in the \"risk group,\" a consultation with a neurologist is planned to establish examination protocols and identify the etiopathogenetic basis for potential developmental disorders. Standard methods of neurological examination will be utilized to assess the development of motor, sensory, cognitive, speech, emotional, communicative, and behavioral parameters in conjunction with anamnestic data and the overall state of somatic health.\n4. Assessment of Reproductive Health:\n\nThe study will also evaluate the effect of ICSI, particularly in cases of male infertility, on the reproductive health and development of 200 male children under three years of age, in comparison with children conceived via classic IVF. This evaluation will involve objective examinations conducted by a pediatric andrologist to investigate the prevalence of urogenital pathology, supplemented by ultrasounds of the scrotum, kidneys, and bladder. Additionally, hormonal status will be assessed by Inhibin B and Anti-Müllerian Hormone (AMH). Anamnestic data will be collected to explore the relationship between the reproductive health of fathers and their sons born after ICSI.\n\n3\\) Methods of Data Collection and Processing Data Collection Sources of Information: Data will be sourced from the International clinical center of the reproductology \"PERSONA\" and Institute of Reproductive Medicine (IRM clinic), in addition to direct examinations of participants based",[187,27,188,189,190,191],"Children","Anthropometric Characteristics","Somatic Health Status","Neurological Condition","Urogenital Pathology",[27,193,194,195,196,197,198],"health status","children after ART","offspring","urogenital pathology","anthropometric charachteristics","neurological conditions","2025-12-09",{"date":201,"type":33},"2025-12-12",{"date":203,"type":33},"2025-10-01",{"date":205,"type":21},"2027-11-30",{"name":207,"class":40},"Kazakhstan's Medical University \"KSPH\"",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":130,"minAge":18,"maxAge":216,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":79},"100553303","phase-1-rv630---approach-to-control-hiv-with-immune-enhancement-and-vaccination-achiev-100553303","NCT06484335","RV630 - Approach to Control HIV With Immune Enhancement and Vaccination (ACHIEV","RV630 - Approach to Control HIV With Immune Enhancement and Vaccination (ACHIEV): Safety and Efficacy of Broadly Neutralizing Antibodies Combined With Therapeutic Vaccination for the Induction of HIV Remission","ACHIEV","Inclusion\u002FExclusion Step 1 Inclusion Criteria (Groups 1 and 2 only)\n\nParticipants are eligible to be included in the protocol Step 1 only if all of the following criteria are met:\n\n1. Thai National\n2. Age ≥18 and ≤60 years of age\n3. Can read and write Thai\n4. Able and willing to provide written informed consent\n5. Confirmed HIV-1 infection (nucleic acid testing \\[NAT\\] and\u002For HIV-1 serology positive with confirmatory quantitative HIV-1 viral load) and started ART during acute infection\n6. Uninterrupted treatment with ART (no interruption of ART for ≥7 consecutive days or longer) since ART initiation, for ≥ 48 weeks.\n7. Currently on integrase inhibitor-based ART regimen (excluding long-acting injectable regimens) and no recent (≤8 weeks prior to screening) changes to ART regimen.\n\n   a. There must be at least one documented plasma HIV-1 RNA \\\u003C50 cps\u002FmL after the last ART change prior to screening\n8. Must be medically stable as confirmed by medical history, physical examination, vital signs, and clinical laboratory tests performed at screening, and as per the Investigator's discretion.\n\n   a. If the results of the screening laboratory panel are outside the normal reference ranges, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study after discussion with the Sponsor's Representative.\n9. The following laboratory values at screening:\n\n   1. CD4 T-cell count ≥400 cells\u002Fmm3\n   2. Absolute neutrophil count (ANC) ˃1,000\u002Fmm3\n   3. Hemoglobin \\>11.5 g\u002FdL\n   4. Platelet count ˃150,000\u002Fmm3\n   5. Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73m2 using the re-expressed MDRD equation with Thai racial factor or the CKD-EPI Cystatin C equation.\n   6. Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), alkaline phosphatase (AP), and total bilirubin ≤1.5 x the upper limit of normal (ULN)\n   7. Hepatitis C virus (HCV) antibody negative or HCV RNA negative.\n10. HIV-1 RNA \\\u003C50 copies\u002Fml for ≥48 weeks at screening.\n\n    1. No history of virologic failure. Virologic failure is defined as having two consecutive HIV-1 RNA \\>1000 copies\u002FmL at any time after achieving HIV-1 RNA \\\u003C50 copies\u002FmL\n    2. A single viral load measurement ≥50 but \\\u003C1000 copies\u002FmL, at any time from achieving HIV-1 RNA \\\u003C50 copies\u002FmL to \\> 48 weeks from screening, is allowed provided that it is bracketed by viral loads \\\u003C50 copies\u002FmL\n    3. A single viral load measurements ≥50 but \\\u003C200 copies\u002FmL, within 48 weeks of screening is allowed provided that each is bracketed by viral loads \\\u003C50 copies\u002FmL prior to screening.\n11. Sensitivity test demonstrating the lack of detection of resistant viruses to VRC07-523LS or PGDM1400LS.\n12. For persons of childbearing potential, negative pregnancy test at the screening visit.\n13. Persons of childbearing potential must agree to not become pregnant and use two methods of contraception if engaging in sexual activity that could lead to pregnancy.\n14. Participants engaging in sexual activity that could lead to pregnancy in the partner and who are of reproductive potential must agree to use a condom to avoid pregnancy in a spouse or partner of childbearing potential and to avoid transmitting HIV to an uninfected partner. A condom must be used from the time of screening until the end of the study or until viral suppression in Step 4, whichever occurs first.\n15. Willingness to abstain from sexual intercourse, or use a condom, or partner(s) using preexposure prophylaxis consistently during ATI and until plasma HIV-1 RNA is less than limit of detection after ART restart with all partners that are HIV-uninfected or serostatus unknown.\n16. Passes Test of Understanding (Protocol Section 8.4)\n17. Willing to interrupt and restart ART according to study schedule\n18. Willing to participate and adhere to the prohibitions and restrictions specified in this protocol for the duration of the study visits and follow up. Step 1 Exclusion Criteria (Groups 1 and 2 only)\n\nParticipants who meet any of the following criteria will be excluded from the study:\n\n1. Weight \\\u003C50 kg or \\> 115 kg\n2. Presence of HLA B\\*57:01 allele associated with viral control.\n3. Anyone with contraindication to intramuscular injections, placement of intravenous lines, and blood draws\n4. Acute or serious illness requiring systemic treatment and\u002For hospitalization within 90 days prior to entry.\n5. Any clinically significant acute or chronic medical condition, that in the opinion of the investigator would preclude participation including cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological disorders, that in the opinion of the investigator would preclude participation (e.g., history of seizure disorders, cardiovascular disease, bleeding\u002Fclotting disorder, autoimmune disease, malignancy, poorly controlled asthma, active tuberculosis or other systemic infections, etc.).\n6. Active or chronic hepatitis B virus infection (detectable HBsAg, HBV DNA, or both)\n7. HCV treatment or HCV RNA\\>LOD within the previous 6 months\n8. Receipt of a licensed or Emergency Use Authorization vaccine within 4 weeks prior to study screening or plans to receive live attenuated vaccines within 4 weeks or any other licensed or Emergency Use Authorization vaccine within 2 weeks prior to or 2 weeks after any of the study investigational product administrations.\n9. Plans to receive an MVA-vectored licensed or Emergency Use Authorization vaccine (i.e., smallpox or Mpox vaccine) within 12 weeks prior to or 2 weeks after either of the two study MVA.tHIVconsv4 vaccine administrations.\n10. Receipt of an investigational study agent within 12 months prior to study screening Note: Receipt of a licensed vaccine as an investigational agent for an off-label indication is not exclusionary, subject to investigator discretion and the time limits in exclusion #8.\n11. Previous receipt of immunoglobulin (IgG) therapy Note: Individuals who received IgGs as prophylactic therapy (e.g., for HBV or rabies exposure) \\>12 months prior to screening will not be excluded.\n12. Previous receipt of humanized or human monoclonal antibody whether licensed or investigational Note: Individuals who received monoclonal antibody for the prevention and\u002For treatment of SARS-CoV-2\u002FCOVID-19 \\>12 months prior to screening will not be excluded.\n13. Previous participation in a candidate HIV vaccine study or immune prophylaxis for HIV-1 infection with confirmed receipt of active product or with unknown receipt of active product vs placebo (i.e. remains blinded to what was actually received).\n14. History of use of any immunomodulatory medications within 6 months of study entry including systemic corticosteroids (\\>14 days), immunosuppressants, anti-cancer drugs, interleukins, systemic interferons, systemic chemotherapy, or other medications that the site investigator feels could have an immune modulatory effect Note: Topical or inhaled corticosteroids are not prohibited.\n15. Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines, vaccine products, neomycin, streptomycin, gentamicin or egg products\n16. History of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis in the 2 years prior to enrollment\n17. History of chronic urticaria requiring daily treatment or a history of chronic or recurrent eczema and\u002For atopic dermatitis\n18. History of splenectomy\n19. Pregnant, breastfeeding or planning to become pregnant while enrolled in this study\n20. Major psychiatric illness and\u002For substance use during the past 12 months that in the opinion of the investigator would preclude participation\n\nStep 2 Inclusion Criteria (Group 3 only)\n\nGroup 3 will enter the study in Step 2. Participants are eligible to be included in the Group 3 protocol Step 2 only if all of the following criteria are met:\n\n1. Thai National\n2. Age ≥18 and ≤60 years of age\n3. Can read and write Thai\n4. Able and willing to provide written informed consent\n5. The following laboratory values at screening:\n\n   1. CD4 \\> 200 cells\u002Fmm3\n   2. Absolute neutrophil count (ANC) ˃1,000\u002Fmm3\n   3. Hemoglobin \\>11.5 g\u002FdL\n   4. Platelet count ˃150,000\u002Fmm3\n   5. Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73m2 using the re-expressed MDRD equation with Thai racial factor or the CKD-EPI Cystatin C equation\n   6. Aspartate aminotransferase (AST) (SGOT), Alanine aminotransferase (ALT) (SGPT), alkaline phosphatase (AP), and total bilirubin \\\u003C2x the upper limit of normal (ULN)\n   7. HIV-1 RNA \\> 1,000 copies\u002FmL\n   8. HCV RNA negative\n6. For persons of childbearing potential, negative pregnancy test at the screening visit.\n7. Persons of childbearing potential must agree to not become pregnant and use two methods of contraception if engaging in sexual activity that could lead to pregnancy. Contraception must be used from the time of screening until the end of the study or until viral suppression in Step 4, whichever occurs first.\n8. Participants engaging in sexual activity that could lead to pregnancy in the partner and who are of reproductive potential must agree to use a condom to avoid pregnancy in a spouse or partner of childbearing potential and to avoid transmitting HIV to an uninfected partner. A condom must be used from the time of screening until the end of the study or until viral suppression in Step 4, whichever occurs first.\n9. Willingness to abstain from sexual intercourse, or use a condom, or partner(s) using pre-exposure prophylaxis consistently during ATI and until plasma HIV-1 RNA is less than limit of detection after ART restart with all partners that are HIV-uninfected or serostatus unknown.\n10. Passes Test of Understanding (Protocol Section 8.4)\n11. Willing to interrupt and restart ART according to study schedule\n12. Willing to participate and adhere to the prohibitions and restrictions specified in this protocol for the duration of the study visits and follow up.\n13. Experiencing early acute HIV-1 infection as defined by\n\n    1. blood samples on at least two separate days positive by nucleic acid testing within 21 days of a negative nucleic acid HIV-1 test. OR\n    2. by a positive nucleic acid test or a positive 4th generation EIA in the context of a negative 2nd or negative 3rd generation HIV-1 EIA test\n14. No history of antiretroviral drug use for any indication in the last 30 days\n\nStep 2 Exclusion Criteria (Group 3 only)\n\nParticipants who meet any of the following criteria will be excluded from the study for Group 3:\n\n1. Weight \\\u003C50 kg or \\> 115 kg\n2. Presence of HLA B\\*57:01 allele associated with viral control.\n3. Anyone with contraindication to intramuscular injections, placement of intravenous lines, and blood draws\n4. Acute or serious illness requiring systemic treatment and\u002For hospitalization within 90 days prior to entry.\n5. Any clinically significant acute or chronic medical condition, that in the opinion of the investigator would preclude participation including cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological disorders, that in the opinion of the investigator would preclude participation (e.g., history of seizure disorders, cardiovascular disease, bleeding\u002Fclotting disorder, autoimmune disease, malignancy, poorly controlled asthma, active tuberculosis or other systemic infections, etc.).\n6. Active or chronic hepatitis B virus infection (detectable HBsAg)\n7. HCV treatment or HCV RNA\\>LOD within the previous 6 months\n8. Receipt of a licensed or Emergency Use Authorization vaccine within 4 weeks prior to study screening or plans to receive live attenuated vaccines within 4 weeks or any other licensed or Emergency Use Authorization vaccine within 2 weeks prior to or 2 weeks after any of the study investigational product administrations.\n9. Plans to receive an MVA-vectored licensed or Emergency Use Authorization vaccine (i.e., smallpox or Mpox vaccine) within 12 weeks prior to or 2 weeks after either of the two study MVA.tHIVconsv4 vaccine administrations.\n10. Receipt of an investigational study agent within 12 months prior to study screening Note: Receipt of a licensed vaccine as an investigational agent for an off-label indication is not exclusionary, subject to investigator discretion and the time limits in exclusion #8.\n11. Previous receipt of immunoglobulin (IgG) therapy Note: Individuals who received IgGs as prophylactic therapy (i.e., for HBV or rabies exposure) \\>12 months prior to screening will not be excluded.\n12. Previous receipt of humanized or human monoclonal antibody whether licensed or investigational Note: Individuals who received monoclonal antibody for the prevention and\u002For treatment of SARS-CoV-2\u002FCOVID-19 \\>12 months prior to screening will not be excluded.\n13. Previous participation in a candidate HIV vaccine study or immune prophylaxis for HIV-1 infection with confirmed receipt of active product or with unknown receipt of active product vs placebo (i.e. remains blinded to what was actually received).\n14. History of use of any immunomodulatory medications within 6 months of study entry including systemic corticosteroids (\\>14 days), immunosuppressants, anti-cancer drugs, interleukins, systemic interferons, systemic chemotherapy, or other medications that the site investigator feels could have an immune modulatory effect Note: Topical or inhaled corticosteroids are not prohibited.\n15. Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines, vaccine products, neomycin, streptomycin, gentamicin or egg products\n16. History of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis in the 2 years prior to enrollment\n17. History of chronic urticaria requiring daily treatment or a history of chronic or recurrent eczema and\u002For atopic dermatitis\n18. History of splenectomy\n19. Pregnant, breastfeeding or planning to become pregnant while enrolled in this study\n20. Major psychiatric illness and\u002For substance use during the past 12 months that in the opinion of the investigator would preclude participation\n21. Absolute neutrophil count (ANC) \\\u003C 740 cells\u002Fmm3\n22. Severe Acute Retroviral Syndrome requiring in-patient hospitalization or interfering with participant ability to return for follow-up visits.\n\nStep 3 (ATI) Inclusion Criteria (All Groups) Step 3 will begin after the third and final vaccine (or placebo) administration (end of Step 2). Participant clinical status or laboratory tests may potentially change during Steps 1 and 2. To ensure that participants continue to meet safety criteria for proceeding to ATI, they will be screened (to include all required screening laboratory tests) for Step 3 inclusion criteria at the visit for the third and final vaccine\u002Fplacebo dose (Last Step 2 visit): Step 2, Week 20 for Groups 1 and 2; Step 2, Week 28 for Group 3.\n\nParticipants enrolled in all Groups of the study may proceed with Step 3 if they meet all the following inclusion criteria:\n\n1. Receipt of all doses of the study products and\u002For placebos per protocol in Steps 1 and 2.\n2. Plasma HIV-1 RNA \\\u003C50 copies\u002FmL at the Last Step 2 visit.\n3. CD4 T-cell count ≥400 cells\u002Fmm3 at the Last Step 2 visit. Note: The CD4 T-cell count can be repeated once, provided that the repeat is done within 4 weeks prior to Step 3 entry.\n4. No CDC Category C event after study entry\n5. Documented negative hepatitis B virus (HBV) surface antigen (HBsAg) at the Last Step 2 visit.\n6. Documented negative hepatitis C virus (HCV) antibody (anti-HCV) or negative HCV RNA at the Last Step 2 visit.\n7. For persons of childbearing potential, negative pregnancy test at the first Step 3 visit (Step 3, Week 0).\n8. Persons of childbearing potential must agree to not become pregnant and use two methods of contraception if engaging in sexual activity that could lead to pregnancy.\n9. Willingness to abstain from sexual intercourse, or use a condom, or partner(s) using pre-exposure prophylaxis consistently during ATI and until plasma HIV-1 RNA is less than limit of detection after ART restart with all partners that are HIV-uninfected or serostatus unknown.\n10. Willingness to participate in ATI for up to 50 weeks.\n11. Willingness to restart ART according to study guidelines.\n\nStep 3 (ATI) Exclusion Criteria (All Groups)\n\nEnrolled participants who meet any of the following criteria will be excluded from moving to Step 3:\n\n1. Virologic failure (two consecutive HIV-1 RNA \\>1000 copies\u002FmL) after study entry\n2. Intercurrent illness, new medical diagnosis, laboratory abnormality, sign, or symptom that, in the opinion of the site investigator, would place participant at higher risk of morbidity during ATI.\n3. Receipt of any non-nucleoside reverse transcriptase inhibitor (NNRTI) within 60 days before Step 3 entry.\n4. Receipt of long-acting ART such as long-acting cabotegravir (CAB LA) or long-acting rilpivirine (RPV LA) at any point after study entry.\n5. Failure by the participant to attend three consecutive Step 1 or Step 2 study visits.\n6. Pregnancy or breastfeeding.\n7. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.","60 Years",{"count":218,"type":21},48,[220],"PHASE1","This is a phase I, randomized, double-blind, placebo-controlled clinical trial to investigate the safety of VRC07-523LS and PGDM1400LS in combination with ChAdOx1.tHIVconsv1, ChAdOx1.HIVconsv62 prime, MVA.tHIVconsv4 and A244d11gp120\u002FALFQ vaccination, and the impact on viral load setpoint during analytic treatment interruption (ATI) in people living with human immunodeficiency virus-1 (HIV-1, PLWH) who have initiated or will initiate antiretroviral therapy (ART) during acute HIV-1 infection (AHI).",[223,224,27,225],"HIV Infections","PLWH","Acute HIV Infection","2025-09-15",{"date":228,"type":33},"2025-09-16",{"date":230,"type":33},"2025-03-27",{"date":232,"type":21},"2027-08-01",{"name":234,"class":40},"Henry M. Jackson Foundation for the Advancement of Military Medicine",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":130,"minAge":18,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":22,"phases":245,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":259},"100544889","phase-4-accelerated-art-initiation-for-pwhiv-who-are-out-of-care-100544889","NCT06374758","Accelerated ART Initiation for PWHIV Who Are Out of Care","ACCELERATE a Multisite Prospective Hybrid (Effectiveness-implementation) Type 2 Design, Single-arm, Mixed-methods Study of a Simplified Accelerated ART Initiation Protocol for People With HIV Who Are Out of Care.","ACCELERATE","PLWH Inclusion criteria: Participants must meet ALL the following inclusion criteria\n\n1. 18 years or older at the time of obtaining the informed consent\n2. Speaks English\n3. Able to give consent which includes the ability to understand and comply with study requirements and instructions as judged by clinic or study staff\n4. HIV-1 infection as documented by positive HIV test (positive laboratory HIV 1\u002F2 Antibody differentiation assay or detectable HIV -1 RNA)\n5. Out of care, defined as not had a medical visit with an HIV care provider with prescribing privileges for ≥6 months AND not receiving ART for ≥1 month (by self-report)\n\nSite Staff Inclusion criteria:\n\nParticipants must meet ALL the following inclusion criteria\n\n1. 18 years or older at the time of obtaining the informed consent\n2. HIV care providers, case managers, pharmacists, or administrators involved in administrative or clinical aspects of the intervention at participating sites\n3. Understand the long-term commitment to the study and be willing to participate\n4. Have adequate resources to complete assessments for the duration of the study\n\nExclusion criteria PLWH Exclusion criteria: Participants who meet ANY of the following criteria are excluded\n\n1. Biktarvy (B\u002FF\u002FTAF) contraindicated or not recommended\n\n   1. Known history of chronic kidney disease (creatinine clearance \\\u003C30 mL\u002Fmin) using Cockcroft-Gault formula AND not on chronic dialysis\n   2. Known history of allergy to B\u002FF\u002FTAF components\n   3. Known history of intermediate-high level resistance to B\u002FF\u002FTAF components (score ≥30 on Stanford HIV Drug Resistance Algorithm) in the available medical record (not having a prior genotype or having M184V\u002FI mutation is NOT an exclusion criterion)\n   4. Concomitant use of contraindicated medications: using drug interaction database either Lexicomp® Drug Interactions (category X Avoid combination) or Liverpool HIV Interactions Checker (category Do not Co-administer) or study drug label (USPI) as reference for list of contraindicated meds.\n   5. Pregnant (by self-report) or planning to become pregnant while enrolled in the study\n2. HIV-2 infection\n3. PLWH who are breastfeeding and are not on ART or taking ART without virologic suppression since breastfeeding will not be recommended.\n4. Active opportunistic infections that would require a delay of ART as judged by the HIV care provider and based on current Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV: such as cryptococcal and Tuberculous meningitis, and CMV retinitis.16\n5. Not residing in the state of Missouri at the time of the study or planning to relocate during the study period\n6. Incarcerated at the time of the study enrollment.\n\nSite Staff Exclusion criteria:\n\n1\\) Moving practice location or job relocation within 1 year",{"count":244,"type":21},120,[246],"PHASE4","The main purpose of the study is to evaluate the effectiveness, of the ACCELERATE model of care to achieve HIV viral suppression at Week 24. The study will also assess the acceptability, appropriateness, feasibility, and sustainability of the ACCELERATE model of care. The ACCELERATE model combines a standardized method for outreach, the use of telehealth for rapid access to an HIV care provider, a simplified pre-approved HIV regimen, a free 30-day medication starter supply, and re-linkage to medical care.",[223,27,249],"Noncompliance, Patient","2025-04-18",{"date":252,"type":33},"2025-04-20",{"date":254,"type":33},"2024-04-29",{"date":256,"type":21},"2026-11-01",{"name":258,"class":40},"University of Missouri-Columbia",4,{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":129,"sex":130,"minAge":18,"maxAge":267,"enrollmentInfo":268,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":270,"conditions":271,"keywords":275,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":288},"100541756","cardiometabolic-function-in-offspring-mother-and-placenta-after-assisted-reproductive-technology-100541756","NCT06334003","Cardiometabolic Function in Offspring, Mother and Placenta After Assisted Reproductive Technology","COMPART","Inclusion Criteria:\n\nPregnant women who have either had fertility treatment at Rigshospitalet or Herlev Hospital (FET and fresh ET groups) or are scheduled for prenatal ultrasounds at Rigshospitalet or Herlev Hospital (NC group) will be screened for eligibility. Inclusion must happen before their routine ultrasound scan in 1. trimester.\n\nExclusion Criteria:\n\n* Maternal pregestational diabetes type 1 or 2\n* Non-singleton pregnancies\n* Maternal pregestational BMI \\> 35 kg\u002Fm2\n* Severe maternal co-morbidity\n* Oocyte donation","40 Years",{"count":269,"type":21},600,"The overall objective is to establish the first-of-its-kind longitudinal cohort of pregnant women, biological fathers\u002Fpartners and offspring from pregnancies achieved by frozen embryo transfer (FET), fresh-embryo transfer (fresh ET) and naturally conceived (NC) to investigate maternal cardiometabolic profiles, fetal growth patterns and placental function during pregnancy as well as metabolic and endocrine health in the offspring. Additionally, the aim is to explore genetic and epigenetic patterns in placenta, fetus and parents. As secondary objectives, the investigator group will examine telomere length and minipuberty hormones in children born after FET, fresh-ET and NC.",[27,272,273,274],"IVF","Children, Only","Cardiovascular Disease Other",[276,277,278,272],"Frozen embryo transfer","Cardiovascular","Metabolic","2024-11-20",{"date":281,"type":33},"2024-11-25",{"date":283,"type":33},"2024-05-17",{"date":285,"type":21},"2027-01-01",{"name":287,"class":40},"Rigshospitalet, Denmark",3,{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":130,"minAge":18,"maxAge":296,"enrollmentInfo":297,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":298,"conditions":299,"keywords":303,"overallStatus":308,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":79},"100566910","primary-and-secondary-drug-resistance-mutations-drms-in-hiv-as-a-risk-factor-of-failure-of-art-including-two-drugs-based-regimens-100566910","NCT06661317","Primary and Secondary Drug Resistance Mutations (DRMs) in HIV As a Risk Factor of Failure of ART, Including Two Drugs Based Regimens.","Presence of HIV-1 DRMs As a Risk Factor of Failure of Two Drugs Based ART Regimens, Including LAI ART, in Cohorts of Primary and Secondary DRMs.","Inclusion Criteria:\n\nInclusion criteria were: diagnosis with HIV-1 infection, age 18 years or older.\n\nExclusion Criteria:\n\nLack of HIV genotyping before ART treatment or change of ART","100 Years",{"count":52,"type":21},"The presence of drug resistance mutations (DRMs) in HIV plays an important role in ART effectiveness. Despite very good results of ART, there is constant concern about the emergence of HIV strains with DRMs, what may lead to virological suppression failure. The concerns grow especially among patients treated with two drugs based regimens, including long acting therapies in injections (LAI ART) or regimens used in preexposure prophylaxis (PreP).",[300,301,302,27],"HIV-1-infection","DRM","DRM Gene Mutation",[304,305,301,306,27,307],"HIV","drug resistance mutations","LAI","integrase inhibitors","NOT_YET_RECRUITING","2024-10-24",{"date":311,"type":33},"2024-10-28",{"date":313,"type":21},"2024-11-01",{"date":315,"type":21},"2024-12-30",{"name":317,"class":40},"Medical University of Warsaw",{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":129,"sex":17,"minAge":18,"maxAge":267,"enrollmentInfo":326,"targetDuration":4,"studyType":22,"phases":328,"briefSummary":329,"conditions":330,"keywords":333,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":288},"100513231","ethanol-sclerotherapy-prior-to-art-100513231","NCT05962775","Ethanol Sclerotherapy Prior to ART","The Impact of Ethanol Sclerotherapy Before ART (Assisted Reproductive Technology) Cycle on Cumulative Live Birth Rate in Infertile Women With Endometrioma: A Randomized Controlled Trial","START","Inclusion Criteria:\n\n* AMH\\>0.3 ng\u002Fml\n* unilateral\u002Fbilateral endometrioma\n* Endometrioma diameter 40-100 mm\n\nExclusion Criteria:\n\n* 3 or more IVF\u002Fembryo transfer failure\n* Menstrual cycle abnormalities\n* Male Factor infertility\n* Presence of uterine fibroids\n* Presence of hydrosalpinx\n* Presence of uterine abnormalities\n* Suspicion of malignancy according to International Ovarian Tumor Analysis criteria",{"count":327,"type":21},84,[54],"The goal of this randomized controlled trial is to assess the impact of ethanol sclerotherapy on ART cycle outcomes. The main questions it aims to answer are:\n\n1. Does ethanol sclerotherapy before ART cycle has any impact on cumulative live birth rate in patients with endometrioma?\n2. Does ethanol sclerotherapy improve chronic pelvic pain, dysmenorrhea, complications during oocyte retrieval, response to ovarian stimulation (number of mature oocytes retrieved), and pregnancy loss rates?\n\nInfertile patients with endometrioma between 4-10 cm who are scheduled for ART within 2 cycles will be randomized to ethanol sclerotherapy or no intervention.",[331,58,332,27,272],"Endometrioma","Sclerotherapy",[334,335,336,337,338],"endometrioma","ethanol sclerotherapy","assisted reproductive technology","in vitro fertilization","cumulative live birth rate","2024-10-13",{"date":341,"type":33},"2024-10-16",{"date":343,"type":33},"2023-05-01",{"date":345,"type":21},"2026-04-01",{"name":347,"class":40},"Ankara University",{"id":349,"slug":350,"hasResults":11,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":129,"sex":130,"minAge":4,"maxAge":18,"enrollmentInfo":356,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":358,"conditions":359,"keywords":364,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":79},"100335700","ivf-offspring-born-in-guangzhou-100335700","NCT03650829","IVF Offspring Born in Guangzhou","IVF Offspring Born in Guangzhou Cohort Study","IVF-BIG","Inclusion Criteria:\n\n* Pregnant women with \\\u003C20 weeks of gestation\n* Pregnant women intended to eventually deliver in Guangzhou Women and Children's Medical Center\n* Permanent residents or families intended to remain in Guangzhou with their child for ≥3 years\n* Pregnant women conceived by assited reproductive technology\n\nExclusion Criteria:\n\n• None",{"count":357,"type":21},3000,"The IVF Offspring Born in Guangzhou Cohort Study (IVF-BIG) was established to investigate the short- and long-term effects of exposure in early life on the health of mothers and offspring in Guangzhou, China. Data are collected regarding assisted reproductive technology (ART), environmental, occupational and lifestyle exposures as well as health outcomes in their later life. Biological samples including blood and tissue samples are also collected from participants.",[27,360,361,362,363],"Offspring, Adult","Genetics","Host and Microbiome","Neurodevelopment",[27,365,366,367],"Offspring","Development","Cohort","2024-02-22",{"date":370,"type":33},"2024-02-26",{"date":372,"type":33},"2012-02-01",{"date":374,"type":21},"2038-12-31",{"name":376,"class":40},"Guangzhou Women and Children's Medical Center",{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":130,"minAge":18,"maxAge":296,"enrollmentInfo":384,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":386,"conditions":387,"keywords":393,"overallStatus":308,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":4},"100519534","the-influence-of-primary-hiv-1-drug-resistance-mutations-on-immune-reconstruction-in-plwh-100519534","NCT06044792","The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH","The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in Patients Treated With Antiretroviral Drugs - an Observational Cohort Study.","Inclusion Criteria:\n\n* HIV-1 confirmed infection\n* ART naive patients \\> 18 years\n* virological suppression after 6 months of ART\n* available results of HIV genotyping before the start of ART\n\nExclusion Criteria:\n\n* hematologic neoplasms\n* use of chemotherapy, immunosuppressive drugs and other myelotoxic agents\n* lack of patient's consent to participate in the study",{"count":385,"type":21},50,"Since the reasons for differential immune reconstitution in HIV-infected patients are still not fully understood, we considered it reasonable to investigate whether the presence of primary HIV drug resistance mutations could be one of the factors of inadequate immune reconstitution.\n\nEvaluation of unfavorable factors of immune reconstitution can help identify patients at risk of persistently low CD4 cell counts and CD4:CD8 ratios and requiring careful monitoring for progression to AIDS.",[388,389,390,27,391,392],"Hiv","AIDS","CD4 Deficiency","Treatment Resistant Disorders","Treatment-Sensitive HIV Infection",[304,394,301,395,396],"CD4","drug resistance","immune reconstruction","2023-09-17",{"date":399,"type":33},"2023-09-21",{"date":401,"type":21},"2023-09-30",{"date":403,"type":21},"2028-01-01",{"name":317,"class":40}]