[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589155":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":72,"studyPopulation":60,"armGroups":73,"interventions":85,"overallOfficials":60,"centralContacts":93,"locations":60,"responsibleParty":103,"collaborators":60,"id":107,"slug":60,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":114,"sex":115,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":60,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":60,"overallStatus":127,"whyStopped":60,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":60},{"fullName":5,"class":6},"The First Affiliated Hospital of Zhengzhou University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":60,"otherOutcomes":60},[9,13,16,19,23,26,29,32,35,38,41,44,47,50,53,56],{"measure":10,"description":11,"timeFrame":12},"Follicle Counting","Transvaginal ultrasound was performed using the Voluson S8 color Doppler ultrasound system (GE, USA) to measure the diameter and number of follicles in both ovaries.","At the time of the first medication administration and on days 2-3 of the menstrual cycle during the second month of medication",{"measure":14,"description":15,"timeFrame":12},"Serum AMH Levels","Blood samples for AMH were collected on days 2-3 of the menstrual cycle before ovarian stimulation.",{"measure":17,"description":18,"timeFrame":12},"Serum FSH Levels","Blood samples for FSH were collected on days 2-3 of the menstrual cycle before ovarian stimulation.",{"measure":20,"description":21,"timeFrame":22},"ART outcomes assessed by the number of clinically viable embryos and clinical pregnancy rates","number of top-quality day 3 embryos and transferable embryos ；the blastocyst formation rate；the number of clinically usable embryos；clinical pregnancy rates","From embryo transfer to the 14-day post-transfer clinical observation period",{"measure":24,"description":25,"timeFrame":12},"Serum LH Levels","Blood samples for LH were collected on days 2-3 of the menstrual cycle before ovarian stimulation.",{"measure":27,"description":28,"timeFrame":12},"Serum P Levels","Blood samples for P were collected on days 2-3 of the menstrual cycle before ovarian stimulation.",{"measure":30,"description":31,"timeFrame":12},"Serum E2 Levels","Blood samples for E2 were collected on days 2-3 of the menstrual cycle before ovarian stimulation.",{"measure":33,"description":34,"timeFrame":12},"Serum Testosterone levels","Blood samples for testosterone were collected on days 2-3 of the menstrual cycle before ovarian stimulation.",{"measure":36,"description":11,"timeFrame":37},"Antral Follicle Count Retrived","Immedietly after oocyte retrived",{"measure":39,"description":40,"timeFrame":37},"Oocytes Retrived","Number of oocytes retrieved in Antagonist Protocol",{"measure":42,"description":43,"timeFrame":12},"NAD+ Levels in PBMCs","NAD+ levels and NAD+\u002FNADH in PBMCs before and after medication",{"measure":45,"description":46,"timeFrame":37},"NAD+ Levels in GCs","NAD+ levels and NAD+\u002FNADH in GCs",{"measure":48,"description":48,"timeFrame":49},"Number of Day 3 embryos","Day 3 of Embryo Culture",{"measure":51,"description":52,"timeFrame":49},"Number of Day 3 top-quality embryos","embryos cultured to the third day post-fertilization that meet specific morphological criteria for optimal quality",{"measure":54,"description":55,"timeFrame":49},"Number of transferable embryos","total number of embryos that meet predefined laboratory criteria for potential implantation",{"measure":57,"description":58,"timeFrame":59},"Blastocyst Formation Rate","Blastocyst Formation Rate (BFR) = (Number of embryos reaching blastocyst stage ÷ Total embryos cultured to Day 5-6) × 100%","Day 6 of Embryo Culture",null,{"allocation":62,"interventionModel":63,"interventionModelDescription":60,"primaryPurpose":64,"observationalModel":60,"timePerspective":60,"maskingInfo":65},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":66,"maskingDescription":60,"whoMasked":67},"QUADRUPLE",[68,69,70,71],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Patients received daily oral supplementation of either nicotinamide riboside (NR, 600 mg\u002Fday) or vitamin E (200 mg\u002Fday) for two consecutive months, initiated on day 2 of the menstrual cycle. Participants were enrolled if they planned to undergo in vitro fertilization\u002Fintracytoplasmic sperm injection (IVF\u002FICSI) with a gonadotropin-releasing hormone (GnRH) antagonist protocol following the intervention period.\n\nBiological Samples\n\nPeripheral blood mononuclear cells (PBMC) were isolated from venous blood.\n\nFollicular fluid containing granulosa cells and discarded oocytes were collected during routine oocyte retrieval procedures.\n\nHormonal and Ovarian Assessments\n\nBaseline measurements: Blood samples were obtained on day 2-3 of the menstrual cycle prior to medication initiation to assess basal endocrine profiles (FSH, LH, E2, P, T, PRL) and anti-Müllerian hormone (AMH) levels.\n\nPost-intervention measurements: Repeat hormonal evaluations and transvaginal ultrasound assessments (antral follicle count \\[AFC\\]) were performed on day 2-3 of the third menstrual cycle after two months of supplementation.",[74,80],{"label":75,"type":76,"description":77,"interventionNames":78},"NR","EXPERIMENTAL","experimental group: 600 mg\u002Fd of oral NR, NIAGEN for two months",[79],"Dietary Supplement: NR",{"label":81,"type":76,"description":82,"interventionNames":83},"Vit E","control group: 200 mg\u002Fd of oral Vitamin E for two months",[84],"Dietary Supplement: Vit E",[86,90],{"type":87,"name":75,"description":88,"armGroupLabels":89,"otherNames":60},"DIETARY_SUPPLEMENT","600 mg\u002Fd of oral NR for two months",[75],{"type":87,"name":81,"description":91,"armGroupLabels":92,"otherNames":60},"200 mg\u002Fd of oral Vitamin E for two months",[81],[94,99],{"name":95,"role":96,"phone":97,"phoneExt":60,"email":98},"Qingling Yang, Ph.D.","CONTACT","+8666271879","qingling531@163.com",{"name":100,"role":96,"phone":101,"phoneExt":60,"email":102},"Mengchen Wang, Master","+86 66271879","wmc13949362871@163.com",{"type":104,"investigatorFullName":105,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":60,"oldOrganization":60},"PRINCIPAL_INVESTIGATOR","Qingling Yang","Associate Research Fellow","100589155",false,"NCT06950736","NR vs. Vitamin E in Enhancing Fertility","Nicotinamide Riboside vs. Vitamin E for Enhancing Fertility in Advanced Maternal Age: A Randomized Parallel Trial","NRVEERSAAM","Inclusion Criteria:\n\n1. Infertile women aged between 35 and 42 years;\n2. 0.1 ng\u002FmL \\\u003C= AMH \\\u003C= 1.1 ng\u002Fml;\n3. Pregnancy aids who plan to perform in vitro fertilization and embryo transfer (antagonist program);\n4. Bilateral ovaries are present;\n5. Patients who voluntarily signed the informed consent and agreed to be followed up according to the requirements of the study protocol.\n\nExclusion Criteria:\n\n1. Adenomyosis and uterine fibroids compression of uterine uterine line;\n2. Untreated bilateral hydrosalpinx;\n3. Uncured endometrial disease;\n4. Any pregnancy occurred within 3 months before screening;\n5. Patients with clinically significant abnormal cervical examination results within 3 months before screening;\n6. Use of fertility regulators (such as clomiphene citrate, GnRH, metformin or oral contraceptives) within 1 month before randomization;\n7. Use hormone drugs within 1 month before randomization;\n8. Patients with acute infection of urinary and reproductive system;\n9. Patients with major systemic diseases, endocrine or metabolic abnormalities that are not suitable to participate in this study, as judged by the investigator;\n10. According to the judgment of the investigator, the presence of uterus (such as submucosal uterine fibroids, intermural uterine fibroids larger than 3 cm or smaller than 3 cm but affecting uterine cavity morphology, untreated endometrial polyps, uterine adhesions, uterine malformations, and ASRM stage Ⅲ-Ⅳ endometriosis). Patients with clinically significant ovarian (e.g., polycystic ovaries, ovarian cysts \\> 4 cm, inability to retrieve eggs from both or one ovary) or adnexa (e.g., hydrosalpinx) abnormalities;\n11. Patients with unexplained abnormal uterine bleeding;\n12. Patients with a history of ovarian, breast, uterus, hypothalamus, pituitary and other malignant tumors;\n13. Receive donor egg or embryo preimplantation genetic screening\u002Fembryo preimplantation genetic diagnosis (PGS\u002FPGD);\n14. Known past or current thromboembolic disease;\n15. Have a known serious mental illness or fail to understand the purpose and methods of the clinical trial, or fail to comply with the study procedures;\n16. Patients with contraindications or allergic history to the use of GnRH-a, r-hFSH, hCGα, progesterone;\n17. Those who are addicted to alcohol, tobacco, drugs or drug abuse;\n18. Being exposed to teratogenic amounts of radiation, poisons and drugs and in the action period;\n19. Patients with liver function injury, that is, serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were 2.5 times higher than the upper limit of normal values;\n20. Persons who are HIV or syphilis positive;\n21. Those with positive serum pregnancy tests;\n22. Other reasons why the researcher considers it inappropriate to participate in the study. Suffers from a disease that is not suitable for the present assisted reproductive technology or for the present pregnancy;\n23. Participants who had participated in other clinical trials within 3 months prior to screening.",true,"FEMALE","35 Years","42 Years",{"count":119,"type":120},60,"ESTIMATED","INTERVENTIONAL",[123],"NA","This randomized controlled trial enrolled women of advanced maternal age (≥35 years) undergoing ART, who were allocated to an intervention group (oral nicotinamide riboside, NR) or a control group (oral vitamin E, VitE) for a 2-month pre-ART intervention. The study systematically evaluated NR's regulatory effects on ovarian function and ART outcomes by measuring NAD+ levels in ovarian granulosa cells (GCs) and peripheral blood mononuclear cells (PBMCs), anti-Müllerian hormone (AMH) concentrations.",[126],"Infertility Female","NOT_YET_RECRUITING","2025-04-27",{"date":130,"type":131},"2025-04-30","ACTUAL",{"date":133,"type":120},"2025-05-05",{"date":135,"type":120},"2027-12-01",{"name":5,"class":6}]