[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Instituto Valenciano de Infertilidad, IVI VALENCIA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":163},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,80,109,136],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100607240","functional-development-and-clinical-validation-of-a-diagnostic-tool-based-on-artificial-intelligence-for-the-assessment-of-sperm-quality-and-the-selection-of-the-optimal-in-vitro-fertilisation-ivf-treatment-100607240",false,"NCT07185984","Functional Development and Clinical Validation of a Diagnostic Tool Based on Artificial Intelligence for the Assessment of Sperm Quality and the Selection of the Optimal In Vitro Fertilisation (IVF) Treatment","* Inclusion criteria:\n\n  * Men between the ages of 18 and 50 who come to the clinic to undergo an ICSI cycle.\n  * Men between the ages of 18 and 50 who come to the clinic to undergo an artificial insemination cycle.\n  * All embryos will be placed in a time-lapse incubator.\n  * All women over 18 years of age who have obtained a MII number greater than or equal to 2 in oocyte retrieval, without excluding couples from the oocyte donation programme.\n  * All men and women with a previously known normal karyotype.\n  * Informed consent (IC) provided and signed by patients.\n* Exclusion criteria:\n\n  * All women diagnosed with recurrent pregnancy loss.\n  * All semen samples obtained by testicular biopsy.\n  * All donor semen samples.","MALE","18 Years","50 Years",{"count":19,"type":20},200,"ESTIMATED","OBSERVATIONAL","Infertility is a growing global health problem affecting millions of couples worldwide, with male infertility accounting for approximately half of all cases. In the physiological environment, sperm go through an exhaustive selection process in the female reproductive tract before reaching the oocyte. During this journey, progressive mobility and morphology are key parameters for achieving fertilisation. Therefore, before starting an assisted reproduction treatment, it is essential to analyse and process the semen sample to assess the fertile potential, select the most optimal sperm and determine the most appropriate treatment.\n\nConventional methods of semen processing, such as density gradient centrifugation (DGC) and Swim-up washing of motile sperm, have significant limitations. These include interobserver and interlaboratory subjectivity, as well as damage to sperm DNA caused by centrifugation. Alternatively, microfluidics, which simulates natural selection, allows higher counts of morphologically normal, progressive motile sperm to be obtained. On the other hand, the CASA (computer-assisted sperm analysis) system has improved the standardisation and quality of semen analysis. Furthermore, the incorporation of Artificial Intelligence (AI) into semen quality analysis represents a promising opportunity, as it improves efficiency, accuracy and standardisation, and has the potential to increase success rates in assisted reproduction treatments.\n\nThis project aims to develop an innovative AI-based diagnostic tool to address male infertility. The tool will integrate microfluidic technology and the CASA system to analyse semen quality, calculate fertilisation potential and recommend personalised treatments with an estimate of success. Trained with large volumes of biological and clinical data, it will provide a comprehensive and patient-specific diagnosis by identifying complex relationships between multiple variables. Finally, a comparative study will be conducted to evaluate laboratory indicators and clinical outcomes of cycles using this tool versus those using conventional methods.",[24,25,26],"Infertility (IVF Patients)","Male Fertility","Sperm Selection",[28,29,30,31],"Male infertility","Microfluidics","Artificial intelligence","Sperm quality","NOT_YET_RECRUITING","2025-09-19",{"date":35,"type":36},"2025-09-22","ACTUAL",{"date":38,"type":20},"2025-11",{"date":40,"type":20},"2027-11",{"name":42,"class":43},"Instituto Valenciano de Infertilidad, IVI VALENCIA","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":16,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100530926","usefulness-of-corifollitropin--as-alternative-to-conventional-daily-rfsh-protocols-in-oocyte-donors-undergoing-pituitary-suppression-with-medroxiprogesterona-acetate-mpa-100530926","NCT06193135","Usefulness of Corifollitropin α as Alternative to Conventional Daily rFSH Protocols in Oocyte Donors Undergoing Pituitary Suppression With Medroxiprogesterona Acetate (MPA)","TROPIX","Inclusion Criteria:\n\n* Signature of the subject's informed consent prior to any trial-related activity.\n* Age between 18 and 35 years (both inclusive).\n* Regular menstrual cycle, from 25 to 35 days (both inclusive).\n* Absence of physical and psychological illness at the time of donation at the discretion of the investigator.\n* BMI 18-28 kg\u002Fm2 (both inclusive) at the time of donation.\n* No personal or family history of interest at the discretion of the investigator.\n* Normal uterus and ovaries, without organic pathology.\n* No polycystic ovaries.\n* Antral follicle count greater than 12 in the sum of the two ovaries at the time of the screening visit.\n* Normal karyotype.\n* Negative infectious disease screening (Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus and Syphilis).\n* General analysis with hemogram, hemostasis and biochemistry with parameters within normality.\n\nExclusion Criteria:\n\n* Concurrent participation in another clinical trial.\n* Previous participation in this clinical trial.\n* Use of long-term hormonal contraception (hormonal IUD or subcutaneous implants) at least 1 month prior to enrollment.\n* Any systemic or metabolic disorder (i.e.: diabetes...) that contraindicates the use of gonadotropins.\n* Personal history of thrombophlebitis and thromboembolic phenomena and hypertension.\n* Severe hepatic insufficiency, cardiovascular disease\n* Suspicion or evidence of breast malignancy or hormone-dependent genital organs.\n* Known hypersensitivity to AMP or its excipients\n* Any reason for exclusion from the oocyte donation program.","FEMALE","35 Years",{"count":55,"type":20},318,"INTERVENTIONAL",[58],"NA","IVF patients frequently experience physical, emotional or physicological burden; this is particularly relevant in the case of oocyte donors, since young women undergo a procedure that is of no health benefit to them. One of the phases of the treatment that contributes most to this situation is ovarian stimulation; as it involves the administration of daily injections which, in addition to the discomfort of administration, causes anxiety to the patient about its correct administration and possible side effects and to physicians concerns about patient compliance.\n\nAdvances in pharmacology and knowledge of ovarian pathophysiology have led to the development of new protocols that simplify and reduce drug administration, decrease the potential risk of misapplication and contribute to an improved patient experience. In this context, Corifollitropin α, a long-acting recombinant FSH (rFSH) molecule, provides with a single subcutaneous injection similar results as daily administration of rFSH during a week.\n\nOn the other hand, conventional stimulation protocols used in ART resort to using a GnRH analogue (agonist or antagonist) to prevent early luteinization, which is defined as the presence of a progesterone value of \\> 1.5 ng\u002Fml on the day of induced ovulation. Nevertheless, its use presents some disadvantages, such as it being sometimes complex to achieve desensitization or consistent hypothalamic block, risk of OHS when ovulation is triggered with HCG or its cost. Hence the interest in exploring new options to prevent a premature peak in LH. Nowadays, the oral administration of progestagens (progesterone-primed ovarian stimulation \\[PPOS\\]) during the follicular phase of ovarian stimulation (OS) has emerged as an attractive alternative to conventional protocols for preventing early luteinization. Moreover, PPOS produces a similar or even better, in some subgroups, response to OS (length of treatment, number of MII, cancelation rate, etc.), reproductive outcomes (pregnancy rate, live birth rate, etc) and safety (rate of ovarian hyperstimulation \\[OHSS\\] or congenital malformations).\n\nThus, PPOS would seem to be an effective option for personalized protocols, particularly when fresh embryo transfer (FET) is not to be performed, a circumstance that is likely to rise in frequency given the progressive increase in women's age at childbearing; for example, in oocyte donation, or in fertility preservation (FP) and preimplantation genetic testing for aneuploidy (PGT-A). However, very little data are available regarding cycle outcome following Corifollitropin α and PPOS as pituitary suppressor.\n\nThe present study, a prospective RCT, was designed to evaluate cycle characteristics (MII oocytes as the primary objective) and endocrinologic profiles of oocyte donors receiving Corifollitropin α and MPA as co-treatment compared with those receiving a daily dose of rFSH (follitropin β) as a control.",[61,62],"Infertility, Female","Reproductive Sterility",[64,65,66,67,68,69],"Oocyte donation","Corifolitropin alpha","Premature luteinization","Medroxiprogesterone acetate","Controlled ovarian estimulation","Folitropin beta","RECRUITING","2025-09-09",{"date":73,"type":36},"2025-09-15",{"date":75,"type":36},"2025-07-08",{"date":77,"type":20},"2025-12-31",{"name":42,"class":43},2,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":88,"minAge":16,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":56,"phases":91,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":4},"100605533","use-of-the-sidtm-v20-algorithm-to-assist-embiyologists-in-sperm-selection-during-icsi-procedures-100605533","NCT07163754","Use of the SiDTM v2.0 Algorithm to Assist Embiyologists in Sperm Selection During ICSI Procedures","Use of the SiDTM v2.0 Algorithm to Assist Embryologists in Sperm Selection During ICSI Procedures: Impact in Biological and Clinical Outcomes","SID_3","Inclusion Criteria:\n\n* Patients with indication for ICSI.\n* Women of advanced maternal age (\\>35 years) in whom at least 4 oocytes in metaphase II stages are obtained in the follicular puncture, without excluding patients from the oocyte donation program.\n* Sperm obtained by masturbation with a concentration above 1 million spermatozoa\u002FmL after sperm capacitation.\n* Normal karyotype of both partners.\n* Informed Consent (IC).\n\nExclusion Criteria:\n\n* Patients diagnosed with recurrent gestational loss.\n* Semen extracted by testicular biopsy.\n* Semen samples with globozoospermia (sperm defect due to lack of acrosome) or azoospermia (absence of spermatozoa in the ejaculate).\n* Semen samples treated with pentoxifylline.\n* ICSI cycles with application of calcium ionophore. o ICSI cycles with application of calcium ionophore.","ALL",{"count":90,"type":20},100,[58],"Infertility is defined as a failure of a couple to achieve a pregnancy after 12 or more months of unprotected intercourse. Males are found to be solely responsible for 20-30% of infertility cases but contribute to 50% of cases overall. The selection of sperm to microinject is completely subjective and there is high intra- and inter- observer variability. SiDTM v2.0 is an algorithm which analyses real-time seminal samples located at ICSI dishes. Particularly, it assesses morphology and several motility parameters of each sperm, and it assigns a categorical and numerical score to each one. Categorical scores are represented by colours: green colour for optimal sperm, yellow for good sperm, orange for medium-quality sperm and red for low-quality sperm. Numerical scores ranged from 0 to 100, with higher scores for those best-quality sperm. SiDTM v2.0 can reduce subjectivity of the sperm selection process to the maximum, selecting the optimal sperm in real time. In addition, it could help junior embryologists to perform this complex and tedious procedure, which is the sperm selection for ICSI. To carry out the study, we will conduct a prospective cohort study in a total of 100 couples. Therefore, the aim of this study is to validate SiDTM v2.0 as an useful Artificial Intelligence-tool for sperm selection; that means achieving , at least, same clinical results as sperm selection performed by the embryologist.",[25,94,95,26],"Testicular","Sperm Parameters in Fertile and Infertile Men",[97,98,99,100,101],"Intracytoplasmatic Sperm injection","automated sperm selection","artificial intelligence","fertilization","embryo quality","2025-09-02",{"date":71,"type":36},{"date":105,"type":20},"2025-10",{"date":107,"type":20},"2027-10",{"name":42,"class":43},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":116,"sex":52,"minAge":16,"maxAge":17,"enrollmentInfo":117,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":44},"100496946","impact-of-serum-progesterone-levels-on-the-day-of--hcg-test-in-artificial-cycles-on-the-ongoing-pregnancy-rate-100496946","NCT05750849","Impact of Serum Progesterone Levels on the Day of β-hCG Test in Artificial Cycles on the Ongoing Pregnancy Rate.","P4-BETA","Inclusion Criteria:\n\n* The subject must provide written informed consent prior to any study related procedures\n* Women ≤50 years old\n* BMI ≤ 35 kg\u002Fm2\n* Adequate endometrial thickness (\\>6.5mm) and pattern (Triple A structure) in the proliferative phase\n\nExclusion Criteria:\n\n* Uterine Pathology, adnexal pathology\n* Systemic diseases",true,{"count":118,"type":20},900,"Prospective cohort multicentric study including infertile patients undergoing a pregnancy test on βhCG day (around ET +11), after an ET in the context of an artificial cycle and receiving LPS with vaginal natural progesterone following the clinical practice in IVI RMA (Spain).",[61],[122,123,124,125,126,127],"SERUM PROGESTERONE","LATE LUETEAL PHASE","ONGOING PREGNANCY RATE","ARTIFICIAL CYCLE","LUTEAL PHASE SUPPORT","EMBRYO TRANSFER","2025-07-16",{"date":130,"type":36},"2025-07-20",{"date":132,"type":36},"2023-01-25",{"date":134,"type":20},"2025-12",{"name":42,"class":43},{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":88,"minAge":16,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":56,"phases":145,"briefSummary":146,"conditions":147,"keywords":150,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":79},"100545660","study-of-the-zymt-sperm-selection-method-and-its-effect-on-embryo-ploidy-100545660","NCT06384794","Study of the ZyMōt Sperm Selection Method and Its Effect on Embryo Ploidy.","ZYMOT2","Inclusion Criteria:\n\n* Couples undergoing an ICSI cycle with PGT-A (Preimplantational Genetic Test for Aneuploidy).\n* Males over 18 years of age whose semen sample meets the basic conditions predetermined by the ZyMōt Multi 850µL chip.\n* Fresh semen samples.\n* Embryos are to be deposited in a time-lapse incubator.\n* Women over 37 years of age who have obtained in follicular puncture a number of MII oocytes greater than or equal to 4.\n\nExclusion Criteria:\n\n* Males with severe asthenozoospermia (\\\u003C10% progressively motile spermatozoa), globozoospermia (spermatozoa with morphological alterations and lack of acrosome) and\u002For azoospermia (absence of spermatozoa in the ejaculate).\n* Seminal samples obtained by testicular biopsy.\n* Samples incubated with calcium ionophore.\n* Males and females with previously known abnormal karyotype.\n* Oocytes coming from the oocyte donation program.",{"count":144,"type":20},80,[58],"It has been described that 11% of men with semen values within the normal range established by the World Health Organization (WHO) have sperm DNA fragmentation. This has been associated with a lower fertilization rate, lower embryo development and, therefore, lower reproductive success. Focusing on the study of the integrity of the male genome can provide us information to diagnose infertility in the couple. The use of conventional sperm selection methods such as swim-up or density gradients has been a great advance in the improvement of male fertility. However, these methods use centrifugation in their protocol, a procedure that has been associated with sperm DNA damage. The ZyMōt is a chip based on microfluidic properties that allows the recovery of spermatozoa with lower DNA fragmentation rate without centrifugation of the semen sample. This new sperm selection method maintains all the advantages of conventional techniques, but decreasing DNA fragmentation associates to sperm recoveries techniques eventually improving reproductive rates. This quality would be beneficial for patients with unexplained infertility, recurrent pregnancy loss or clinical varicocele, factors that have been associated with a higher index of DNA fragmentation. However up to date there is evidence-based data supporting such improvement. The main objective of the present project is to evaluate the ZyMōt as a new non-invasive sperm selection device and to see its impact on the euploidy rate, comparing it with a sperm selection technique that is routinely used in the clinic: swim-up. At the same time, the effect that this new chip may have on sperm and other reproductive variables will be analyzed clinically, and molecularly with immunohistochemical and transcriptomic analyses in order to observe the impact of SDF(sperm DNA fragmentation) at the molecular and genomic level in oocytes with low reparative potential oocytes.",[148,149],"Infertility, Male","Sperm Count, Low",[151,152,153,154],"ZyMöt","Sperm fragmentation","Embryo development","Euploidy","2024-04-25",{"date":157,"type":36},"2024-04-29",{"date":159,"type":36},"2023-06-29",{"date":161,"type":20},"2026-12-31",{"name":42,"class":43},""]