[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"unexplained-infertility\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:unexplained-infertility":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,75,98,121],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100618872","royal-jelly-supplementation-in-unexplained-male-infertility-100618872",false,"NCT07337265","Royal Jelly Supplementation in Unexplained Male Infertility","Effect of Oral Royal Jelly Supplementation on Sperm DNA Fragmentation Index and Pregnancy in Couples With Unexplained Infertility: A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Study","Inclusion Criteria:\n\n* Men aged 18-45 years. History of infertility for at least 1 year despite unprotected intercourse.\n\nDiagnosis of unexplained infertility with Normozoospermia according to WHO 2021 (6th Ed.) criteria:\n\nConcentration ≥ 16 million\u002FmL Total Motility ≥ 42% Progressive Motility ≥ 30% Normal Morphology (Kruger) ≥ 4% Female partner with normal gynecological evaluation (regular ovulation, normal ovarian reserve, and proven tubal patency via HSG).\n\nNormal serum hormone levels (Testosterone, FSH, LH)\n\nExclusion Criteria:\n\n* Any abnormality in spermiogram (Oligo-, Asteno-, or Teratozoospermia). Presence of clinical varicocele. Leukocytospermia (\\>1 million\u002FmL) or active infection. History of smoking (\\>5 cigarettes\u002Fday) or BMI \\> 30 kg\u002Fm². Use of any antioxidant supplementation within the last 3 months.","MALE","18 Years","45 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"NA","This randomized, double-blind, placebo-controlled clinical trial investigates the effects of oral Royal Jelly supplementation on sperm DNA fragmentation and pregnancy rates in couples with unexplained infertility. While routine semen analysis appears normal (normozoospermia) in these patients, underlying Sperm DNA Fragmentation (SDF) and oxidative stress are believed to contribute to reproductive failure.\n\nParticipants will be randomized to receive either 750 mg of lyophilized Royal Jelly or a placebo daily for a period of 3 months (90 days). The study aims to evaluate whether the antioxidant properties of Royal Jelly can improve sperm chromatin integrity, reduce oxidative stress markers, and increase spontaneous pregnancy rates compared to the control group",[27,28,29],"Unexplained Infertility","Male Infertility","Sperm DNA Fragmentation",[31,32,33],"royal jelly","unexplained male infertility","sperm dna fragmentation","NOT_YET_RECRUITING","2026-01-01",{"date":37,"type":38},"2026-01-13","ACTUAL",{"date":40,"type":21},"2026-02-01",{"date":42,"type":21},"2026-08-01",{"name":44,"class":45},"Medipol University","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100615547","icsi-versus-conventional-ivf-in-couples-with-unexplained-infertility-100615547","NCT07294027","ICSI Versus Conventional IVF in Couples With Unexplained Infertility","Intracytoplasmic Sperm Injection (ICSI) Versus Conventional in Vitro Fertilization (IVF) in Couples With Unexplained Infertility: a Multicenter, Open-label, Parallel-group, Randomized Controlled Trial","ICSI\u002FIVF-UI","Inclusion Criteria:\n\n1. Aged 20-38 years\n2. 18.5 \\\u003C BMI \\\u003C 24kg\u002Fm2\n3. Couples diagnosed with primary unexplained infertility:\n\n   * Regular menses or confirmed ovulation;\n\n     * Normal ovarian reserve;\n\n       * Patent fallopian tubes;\n\n         * Normal uterus and cervix;\n\n           * Normal endocrine profile;\n\n             * Semen analysis meeting WHO 6th edition criteria\n\n               * Normal karyotypes in both partners, no family history of genetic disorders\n4. First IVF\u002FICSI cycle\n5. Received GnRH agonist protocol or GnRH antagonist protocol\n6. Willing to provide informed consent and comply with follow-up\n\nExclusion Criteria:\n\n1. Preimplantation genetic testing (PGT) cycles\n2. In vitro maturation (IVM) cycles\n3. Using donor sperm\u002Foocyte\n4. Using frozen sperm\u002Foocyte\n5. \\\u003C5 oocytes retrieved\n6. Abnormal semen parameters on the day of oocyte retrieval\n7. High risk of tubal pathology or endometriosis without laparoscopic exclusion\n8. Untreated or poorly controlled endocrine disorders\n9. Abnormal immune related examinations\n10. Major organ\u002Fsystem disorders (cardiac, hepatic, renal, oncologic, hematologic, psychiatric, etc.)\n11. Concurrent participation in other clinical trials.","FEMALE","20 Years","38 Years",{"count":58,"type":21},848,[24],"This multicenter, open-label, parallel-group, randomized controlled trial aims to compare the live birth rate, fertilization outcomes, other pregnancy outcomes and safety between ICSI and conventional IVF among couples with unexplained infertility in China.",[27],[63,64,65],"Unexplained infertility","Conventional in vitro fertilization","Intracytoplasmic sperm injection","2025-12-07",{"date":68,"type":38},"2025-12-19",{"date":35,"type":21},{"date":71,"type":21},"2028-07-30",{"name":73,"class":45},"Second Affiliated Hospital, School of Medicine, Zhejiang University",7,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100553835","varicocelectomy-in-patients-with-clinical-varicocele-and-unexplained-infertility-100553835","NCT06491251","Varicocelectomy in Patients With Clinical Varicocele and Unexplained Infertility","Outcomes of Varicocelectomy in Patients With Clinical Varicocele and Unexplained Infertility","Inclusion Criteria:\n\n* Patients unable to conceive after 12 month of regular and unprotected intercourse\n* Male patients aged 18 -45 years old\n* Normal semen analysis (concentration, motility and morphology) according to WHO criteria 2021\n* Infertile men with clinical varicocele (grade II,III) subjected to varicocelectomy\n* No history of other congenital or acquired urogenital diseases\n* Primary infertility\n* Normal BMI (18.5-24..9)\n\nExclusion Criteria:\n\n* History of other congenital or acquired urogenital diseases\n* Age outside inclusion criteria\n* Grade I varicocele confirmed by ultrasound ( subclinical varicocele )\n* Abnormal semen analysis\n* Recurrent varicocele\n* Patient unable or unwilling to comply with follow-up schedule\n* Female fertility issues (anovulation , hormonal infertility, tubal factor, endometriosis)",true,{"count":20,"type":21},[24],"This study was conducted to assess the efficacy of varicocelectomy in unexplained male infertility with clinical varicocele The primary objective was to assess the pregnancy outcomes in these group. The secondary objective was to analyses improvement in Sperm DNA fragmentation , hormonal profile and semen parameter after varicocelectomy in Unexplained infertility .",[27],"RECRUITING","2024-06-30",{"date":90,"type":38},"2024-07-09",{"date":92,"type":38},"2023-02-13",{"date":94,"type":21},"2024-08-01",{"name":96,"class":45},"Kafrelsheikh University",1,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":54,"minAge":17,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":97},"100553100","possible-action-of-resveratrol-in-improving-the-outcomes-of-ivficsi-in-couples-with-unexplained-infertility-100553100","NCT06481696","Possible Action of Resveratrol in Improving the Outcomes of IVF\u002FICSI in Couples With Unexplained Infertility","Randomized, Placebo-controlled, Double-blind, Single-center Trial to Evaluate the Possible Action of Resveratrol in Improving the Outcomes of Controlled Ovarian Stimulation During the IVF\u002FICSI Cycles in Couples With Unexplained Infertility","RECOS","Inclusion Criteria:\n\n* Female age 18-40 years\n* Female BMI 18-30 kg\u002Fm2\n* normal menstrual cycles (26-35 days)\n* duration of infertility at least 18 months\n* normal semen parameters as established by WHO laboratory manual for the examination and processing of human semen Sixth edition\n* normal US evaluation of male genital anatomy\n* normal FSH, LH, Prolactin, Total Testosterone, Estradiol in male partner\n* bilateral tubal patency established by 3-D HyFoSy or HSG\n* normal uterine cavity evaluated by 3-D HyFoSy or HSG or hysteroscopy\n* absence of antibodies Anti-Chlamyidia Trachomatis IgG\u002FIgM\n* failed intrauterine inseminations or couple's decision to refuse intrauterine inseminations\n\nExclusion Criteria:\n\n* ≥15 cigarettes per day at least in one of the partners\n* irregular menstrual cycles\n* poor ovarian response (on the basis of the \"Bologna\" Criteria)\n* inaccessible ovaries\n* severe endometriosis (stage III-IV of the ASRM revised classification)\n* significant systemic diseases\n* heterologous fertilization\n* previous pelvic surgery\n* presence of ovarian cysts\n* polycystic ovary syndrome\n* use of hormonal contraception in the previous 3 months\n* use of gonadotrophins in the previous 3 months\n* III stage varicocele","40 Years",{"count":108,"type":21},90,[24],"Based on available evidence and given the potential beneficial effects of resveratrol in folliculogenesis and in oocyte development, the investigators designed a randomized, controlled, double-blind, single-center trial, whose objective will be the comparison of biological and clinical outcomes of resveratrol supplement in women undergoing IVF\u002FICSI cycles for unexplained infertility.\n\nTo the knowledge of the investigators, no study has been published on the potential effect of resveratrol on IVF\u002FICSI outcomes considering couples with this infertility diagnosis, which may be the natural target of this integrative treatment because the process of folliculogenesis and oocyte maturation cannot be routinely investigated. An alteration of these biological mechanisms could be the unrecognized cause of part of the unexplained infertility and treatment with resveratrol could result in significant clinical improvement for the patients enrolled in the study.\n\nIn more details, the main objective of this randomized, placebo-controlled, double-blind, single-center trial will be the evaluation of the possible effect of resveratrol in determining a better follicle development in patients with unexplained infertility undergoing controlled ovarian stimulation (COS) for IVF\u002FICSI.\n\nInfertile female patients with normal ovarian reserve will be treated according to clinical practice and the difference between expected (through AFC) and retrieved oocytes will be assessed in relation to use of resveratrol.",[27],"2024-06-27",{"date":114,"type":38},"2024-07-01",{"date":116,"type":38},"2024-06-01",{"date":118,"type":21},"2025-12-31",{"name":120,"class":45},"Andros Day Surgery Clinic",{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":97},"100375511","iui-with-letrozole-versus-in-natural-cycle-100375511","NCT04169451","IUI With Letrozole Versus in Natural Cycle","Intrauterine Insemination With Letrozole Versus Intrauterine Insemination in Natural Cycle. A Muticenter Randomized Controlled Trial","Inclusion criteria\n\nIn order to be eligible to participate in this study, a participating couple must meet all of the following criteria:\n\n* Being diagnosed with unexplained or mild male infertility\n* At least one sided tubal patency, established according to local protocol\n* Normal or mild impairment of semen quality defined as total motile sperm count (TMSC) no less than 5million, based on at least one recent semen analysis\n\nExclusion criteria\n\nA potential participant who meets any of the following criteria will be excluded from study participation:\n\n* Woman with double sided tubal pathology\n* Women with irregular cycles, PCOS or other endocrine disorders\n* Man with impaired semen quality: total motile sperm count (TMSC) less than 5million",{"count":129,"type":21},982,[24],"Rationale Intrauterine insemination (IUI) is the treatment of first choice for couples with unexplained and mild male factor infertility in many countries, but it is controversial whether ovarian stimulation improves fertility outcomes. In recent retrospectively collected data, we found that in couples with unexplained and mild male factor infertility undergoing IUI, ovarian stimulation with letrozole increased live birth rate as compared to natural cycle IUI without substantially increasing the multiple pregnancy rate. We therefore intend to perform a randomized clinical trial (RCT) on the subject in five reproductive medical centers in different cities in China.\n\nObjective To test the hypothesis that in couples with unexplained or mild male factor infertility scheduled for an IUI program ovarian stimulation with letrozole increases the live birth rate as compared to natural cycle treatment.\n\nStudy design Multicenter randomized controlled trial.\n\nStudy population Women diagnosed with unexplained or mild male factor infertility scheduled for treatment with IUI.\n\nIntervention Women will be randomized for ovarian stimulation with letrozole or to natural cycle IUI. In the group allocated to ovarian stimulation, women will receive oral tablets letrozole 5 mg daily from cycle day 3 for 5 days. We will treat the couples for 3 cycles, with a time horizon of 4 months.\n\nMain study parameters\u002Fendpoints Primary outcome is live birth resulting from conception within 4 months after randomization. Secondary endpoints are clinical pregnancy, multiple pregnancy, miscarriage rates, pregnancy complications, time to pregnancy leading to live birth.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness The strategies compared are already broadly applied in current practice. No additional risks are expected. There is no benefit for participants, but the results may benefit future infertile couples.",[133,27],"Intrauterine Insemination","2024-02-06",{"date":136,"type":38},"2024-02-07",{"date":138,"type":38},"2022-09-29",{"date":140,"type":21},"2026-06",{"name":142,"class":45},"Peking University Third Hospital"]