[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Indira IVF Hospital Pvt Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":159},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,79,108,137],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100640610","clinical-thresholds-of-double-strand-breaks-in-sperms-dna-in-art-100640610",false,"NCT07621991","Clinical Thresholds of Double-strand Breaks in Sperm's DNA in ART","A Prospective Trial Assessing the Impact of Double-strand Breaks on ART Outcomes and Predicting Its Clinical Thresholds","DSBs","Inclusion Criteria:\n\n* Males aged 21-55 years undergoing ICSI treatment for male factor infertility.\n* Women with age 21-35 for self-oocyte pickup cycles\n* Oocyte donor cycles with recipient age of 21-35 years of age\n* Sperm with a minimum total motile sperm count of 2.0 million\u002FmL and a minimum volume of 1.2 mL\n* Patients not underwent sperm DNA fragmentation testing\n* 2-3 days of abstinence prior to intracytoplasmic sperm injection (ICSI).\n\nExclusion Criteria:\n\n* Severe male factor infertility (azoospermia or severe oligozoospermia; for this study defined as no sperm present or sample with \\\u003C2 million\u002Fml sperm count)\n* Known systemic diseases (e.g., diabetes mellitus).\n* Surgically retrieved sperms using testicular sperm aspiration, testicular sperm extraction and percutaneous epididymal sperm aspiration.\n* Untreated endometrial or uterine factors or adnexal pathology\n* Embryos underwent preimplantation genetic testing for aneuploidy testing.\n* Patients with thin endometrium (\\\u003C7mm)\n* Patients opted or underwent donor sperms as the male gamete source.\n* Patients underwent antioxidant treatment in last 6 months prior to ICSI treatment.",true,"ALL","21 Years","55 Years",{"count":22,"type":23},484,"ESTIMATED","OBSERVATIONAL","The goal of this prospective observational study is to learn about the impact of double-strand sperm DNA fragmentation (dsSDF) on assisted reproductive technology (ART) outcomes and to derive clinically relevant threshold values for dsSDF and global sperm DNA fragmentation (SDF) in couples undergoing intracytoplasmic sperm injection (ICSI). The main questions it aims to answer are:\n\n* Can clinically relevant threshold values of dsSDF and global SDF predict live birth rates following ICSI?\n* Does elevated dsSDF reduce live birth rates following ICSI? Participants undergoing ICSI as part of their routine fertility treatment will provide semen samples for global SDF and dsSDF assessment using the R10 Plus and R11 Plus kits, respectively, analysed using the LensHooke® X12 platform before and after sperm preparation. SDF and dsSDF assessments will be performed both prior to and following sperm washing for each participant. Embryos will be assessed from fertilization through embryo development, and following embryo transfer, participants will be prospectively followed for clinical outcomes ranging from biochemical pregnancy to live birth.",[27,28],"Sperm DNA Fragmentation","Sperm DNA Impact on ART Outcomes",[30,31,32,33,34],"Sperm DNA fragmentation","Double-strand sperm DNA fragmentation","LensHooke® X12","ntracytoplasmic sperm injection","Live birth","NOT_YET_RECRUITING","2026-06-03",{"date":38,"type":39},"2026-06-05","ACTUAL",{"date":41,"type":23},"2026-06-01",{"date":43,"type":23},"2027-12-01",{"name":45,"class":46},"Indira IVF Hospital Pvt Ltd","OTHER",2,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100639423","randomized-non-inferiority-within-patient-trial-of-density-gradient-processing-of-sequential-ejaculates-versus-centrifugation-free-sperm-separation-device-for-icsi-in-men-with-elevated-sperm-dna-fragmentation-100639423","NCT07626359","Randomized Non-inferiority Within-Patient Trial of Density Gradient Processing of Sequential Ejaculates Versus Centrifugation-free Sperm Separation Device for ICSI in Men With Elevated Sperm DNA Fragmentation.","SE","Inclusion Criteria:\n\n* • Elevated SDF defined as DFI \\>20 %measured by the sperm chromatin dispersion (SCD) test performed in a participating center's andrology laboratory, using a harmonized protocol under standardized conditions after 2-3 days of ejaculatory abstinence, and within 90 days (≤3 months) prior to enrollment.\n\n  * Male partners 21-45 years;\n  * Female partners 21-35 years.\n  * Undergoing IVF\u002FICSI.\n  * No known genetic or chromosomal abnormalities.\n  * Minimum 4 MII oocyte patients shall be included\n\nExclusion Criteria:\n\n* Azoospermia or severe oligoasthenozoospermia (\\\u003C1 million motile sperm\u002FmL).\n* Significant systemic disease (e.g., uncontrolled diabetes, malignancy).\n* History of a prior ICSI cycle with no embryo development.\n* Relevant female factors: untreated adnexal pathology ,a history of a thin endometrium (\\\u003C7 mm) following endometrium preparation for embryo transfer","45 Years",{"count":57,"type":23},830,"INTERVENTIONAL",[60],"NA","Elevated SDF can adversely impact fertilization, embryo development, and pregnancy outcomes in IVF-ICSI cycles. Two pragmatic strategies aim to reduce SDF on the day of ICSI: (i) obtaining a second ejaculate shortly after the first to reduce oxidative damage and transit time; and (ii) selecting sperm via centrifugation-free sperm separation device, which enriches for motile sperm with intact DNA. There are limited direct comparisons between these strategies; this study addresses that gap.",[63],"Male",[65,66,67,68,69],"pregnancy rate","Second Ejaculate","Abstinence","Microfluidic","CA0","2026-05-30",{"date":72,"type":39},"2026-06-04",{"date":74,"type":23},"2026-08-05",{"date":76,"type":23},"2028-03-25",{"name":45,"class":46},9,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":17,"sex":87,"minAge":4,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":58,"phases":90,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100634509","gonadotropin-therapy-in-idiopathic-hypogonadal-non-obstructive-100634509","NCT07540611","Gonadotropin Therapy in Idiopathic Hypogonadal Non-Obstructive","\"Gonadotropin Therapy in Idiopathic Hypogonadal Non-Obstructive Azoospermia (APHRODITE Groups 3-4): A Multicenter Randomized Controlled Trial\"","GTIHNO","Inclusion Criteria:\n\n\\- Idiopathic NOA; hypogonadal (TT \\\u003C350 ng\u002FdL on two fasting morning tests); FSH ≥7.6 IU\u002FL (APHRODITE Group 3: 7.6-12.0 IU\u002FL; Group 4: \\>12.0 IU\u002FL).\n\nExclusion Criteria:\n\ncryptorchidism, chemo\u002Fradiation, genetic NOA (e.g., AZFa\u002Fcomplete AZFb), testicular trauma\u002Ftorsion, post-orchitis. prior micro-TESE within 12 months; recent gonadotropin therapy (\\\u003C6 months); uncontrolled endocrine disease; active malignancy; severe liver disease; polycythemia (Hct\\>50%); inability to comply. Varicocele\\>= Grade 3","MALE",{"count":89,"type":23},860,[60],"The goal of this clinical trial is to determine whether short-term gonadotropin therapy (hCG + FSH) can increase sperm availability for ICSI in men with idiopathic non-obstructive azoospermia (NOA) and hypogonadism. The main questions it aims to answer are:\n\nDoes hormonal optimization improve the likelihood of obtaining usable sperm (via ejaculate or micro-TESE) by Week 16? Does hormonal therapy reduce the need for micro-TESE or improve downstream embryological and clinical outcomes?\n\nBecause there is a comparison group, researchers will compare hCG + FSH hormonal therapy with standard-of-care (no gonadotropins) to see if hormonal optimization increases sperm retrieval success and decreases surgical reliance.\n\nParticipants will:\n\nUndergo baseline hormonal and semen testing Be randomized to either hormonal therapy or standard-of-care If in the hormonal arm: receive hCG and FSH with monthly dose titration and aromatase inhibitors if indicated Provide semen samples at Weeks 12 and 16 Undergo micro-TESE if no ejaculated sperm are found (timing per protocol) Complete safety assessments and follow-up through Week 16",[93],"APHRODITE Group",[95,96,97,98],"Non-obstructive azoospermia (NOA)","Idiopathic NOA","Male infertility","Hypogonadism","2026-04-14",{"date":101,"type":39},"2026-04-20",{"date":103,"type":23},"2026-07-17",{"date":105,"type":23},"2027-07-17",{"name":45,"class":46},8,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":116,"minAge":19,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":58,"phases":120,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},"100586261","fet-in-adenomyosis-100586261","NCT06913075","FET in Adenomyosis","Is GnRH Agonist Plus Letrozole a Better Choice Than GnRH Agonist Alone in Adenomyosis Cases Undergoing Frozen Embryo Transfer?","ADY","Inclusion Criteria:\n\nDiagnosis of adenomyosis confirmed via transvaginal ultrasound as per MUSA criteria History of infertility requiring frozen embryo transfer (FET). Availability of at least one good-quality frozen embryo for transfer\n\nExclusion Criteria:\n\nBMI ≥ 30 kg\u002Fm2 Presence of endocrine disorders; (uncontrolled diabetes mellitus, \u002F hyperprolactinemia, thyroid dysfunction, Congenital adrenal hyperplasia, Cushing syndrome, or polycystic ovary syndrome Previous major uterine surgery Gestational carrier Fertility preservation","FEMALE","42 Years",{"count":119,"type":23},700,[60],"Purpose of the Study:\n\nTo compare the effectiveness of GnRH agonist downregulation alone versus GnRH agonist combined with letrozole in improving pregnancy outcomes in women with adenomyosis undergoing frozen embryo transfer (FET).\n\nResearch Question:\n\nIs the combined use of GnRH agonist and letrozole more effective than GnRH agonist downregulation alone in achieving better ongoing pregnancy rates in adenomyosis cases undergoing FET?\n\nHypothesis:\n\nNull Hypothesis (H₀): The combined use of GnRH agonist and letrozole is not more effective than GnRH agonist downregulation alone in achieving a higher ongoing pregnancy rate in adenomyosis cases undergoing FET.\n\nStudy Outcomes:\n\nPrimary Outcome: Ongoing pregnancy rate at 12 weeks of gestation.",[123],"Adenomyosis",[125,123,126,127],"Frozen embryo transfer","ongoing pregnancy rate","live birth rate","2026-01-23",{"date":130,"type":39},"2026-01-26",{"date":132,"type":23},"2026-06-25",{"date":134,"type":23},"2026-12-23",{"name":45,"class":46},1,{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":17,"sex":87,"minAge":4,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":156,"leadSponsor":158,"locationsCount":136},"100586166","male-factor-infertility-across-india-using-aphrodite-criteria-100586166","NCT06911840","Male Factor Infertility Across India Using Aphrodite Criteria","Assessment of Male Factor Infertility Across India: An Observational Cross-Sectional Study Using the Aphrodite Criteria, a Hospital-based Study","APHR","Inclusion Criteria:\n\n* All male visiting IVF clinic willingly giving consent for andrological evaluation.\n\nExclusion Criteria:\n\n* NONE",{"count":146,"type":23},1090,"Study Purpose:\n\nThe purpose of this study is to conduct an observational cross-sectional analysis of male factor infertility across diverse regions of India utilizing the Aphrodite Criteria. This novel patient classification system offers a systematic approach to describing and managing male infertility, particularly for hypogonadal males with idiopathic infertility. The study aims to evaluate the current state of male fertility across India and identify any regional variations in male reproductive health and hypogonadism, which may be influenced by environmental, lifestyle, and genetic factors.\n\nStudy Objective:\n\nThe primary objective of this study is to conduct an observational cross-sectional analysis of male factor infertility across various regions of India using the Aphrodite Criteria. To reveal the prevalence and determinants of male factor infertility across different regions of India.\n\nHypothesis:\n\nWe hypothesize that there are significant regional differences in male factor infertility characteristics across India, with variations in sperm quality and testicular function due to diverse environmental, lifestyle, and genetic factors. Additionally, we hypothesize that the application of the Aphrodite Criteria will provide a more detailed classification of male infertility compared to conventional semen analysis and that certain lifestyle factors such as smoking, obesity, and occupational exposures will be associated with poorer sperm quality and testicular function.\n\nStudy Population:\n\nThe study population will consist of male patients visiting clinics across different IVF centers in India. The total sample size includes subjects from five groups with the following distribution:\n\n35 subjects in Group I ; 416 subjects in Group II; 270 subjects in Group III; 152 subjects in Group IV; 216 subjects in Group V\n\nThe total sample size for all groups will be 1,090 subjects.",[149],"Male Infertility Due to Azoospermia",[97,151,152,153],"Azoospermia","Aphrodite criteria","Prevelance",{"date":130,"type":39},{"date":128,"type":23},{"date":157,"type":23},"2026-10-23",{"name":45,"class":46},""]