NR vs. Vitamin E in Enhancing Fertility

NCT06950736 | Not Yet Recruiting

• 1 other identifier: QNCXTD2023017
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Infertility Female

Outcome Measures

Primary Outcomes (16)

• 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

• Serum AMH Levels

  Blood samples for AMH were collected on days 2-3 of the menstrual cycle before ovarian stimulation.

  At the time of the first medication administration and on days 2-3 of the menstrual cycle during the second month of medication

• Serum FSH Levels

  Blood samples for FSH were collected on days 2-3 of the menstrual cycle before ovarian stimulation.

  At the time of the first medication administration and on days 2-3 of the menstrual cycle during the second month of medication

• 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

• Serum LH Levels

  Blood samples for LH were collected on days 2-3 of the menstrual cycle before ovarian stimulation.

  At the time of the first medication administration and on days 2-3 of the menstrual cycle during the second month of medication

• Serum P Levels

  Blood samples for P were collected on days 2-3 of the menstrual cycle before ovarian stimulation.

  At the time of the first medication administration and on days 2-3 of the menstrual cycle during the second month of medication

• Serum E2 Levels

  Blood samples for E2 were collected on days 2-3 of the menstrual cycle before ovarian stimulation.

  At the time of the first medication administration and on days 2-3 of the menstrual cycle during the second month of medication

• Serum Testosterone levels

  Blood samples for testosterone were collected on days 2-3 of the menstrual cycle before ovarian stimulation.

  At the time of the first medication administration and on days 2-3 of the menstrual cycle during the second month of medication

• Antral Follicle Count Retrived

  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.

  Immedietly after oocyte retrived

• Oocytes Retrived

  Number of oocytes retrieved in Antagonist Protocol

  Immedietly after oocyte retrived

• NAD+ Levels in PBMCs

  NAD+ levels and NAD+/NADH in PBMCs before and after medication

  At the time of the first medication administration and on days 2-3 of the menstrual cycle during the second month of medication

• NAD+ Levels in GCs

  NAD+ levels and NAD+/NADH in GCs

  Immedietly after oocyte retrived

• Number of Day 3 embryos

  Number of Day 3 embryos

  Day 3 of Embryo Culture

• Number of Day 3 top-quality embryos

  embryos cultured to the third day post-fertilization that meet specific morphological criteria for optimal quality

  Day 3 of Embryo Culture

• Number of transferable embryos

  total number of embryos that meet predefined laboratory criteria for potential implantation

  Day 3 of Embryo Culture

• 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

Study Arms (2)

NR

EXPERIMENTAL

experimental group: 600 mg/d of oral NR, NIAGEN for two months

Dietary Supplement: NR

Vit E

EXPERIMENTAL

control group: 200 mg/d of oral Vitamin E for two months

Dietary Supplement: Vit E

Interventions

NR DIETARY_SUPPLEMENT

600 mg/d of oral NR for two months

NR

Vit E DIETARY_SUPPLEMENT

200 mg/d of oral Vitamin E for two months

Vit E

Eligibility Criteria

• Age: 35 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Infertile women aged between 35 and 42 years;
• ng/mL \<= AMH \<= 1.1 ng/ml;
• Pregnancy aids who plan to perform in vitro fertilization and embryo transfer (antagonist program);
• Bilateral ovaries are present;
• Patients who voluntarily signed the informed consent and agreed to be followed up according to the requirements of the study protocol.

You may not qualify if:

• Adenomyosis and uterine fibroids compression of uterine uterine line;
• Untreated bilateral hydrosalpinx;
• Uncured endometrial disease;
• Any pregnancy occurred within 3 months before screening;
• Patients with clinically significant abnormal cervical examination results within 3 months before screening;
• Use of fertility regulators (such as clomiphene citrate, GnRH, metformin or oral contraceptives) within 1 month before randomization;
• Use hormone drugs within 1 month before randomization;
• Patients with acute infection of urinary and reproductive system;
• Patients with major systemic diseases, endocrine or metabolic abnormalities that are not suitable to participate in this study, as judged by the investigator;
• 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;
• Patients with unexplained abnormal uterine bleeding;
• Patients with a history of ovarian, breast, uterus, hypothalamus, pituitary and other malignant tumors;
• Receive donor egg or embryo preimplantation genetic screening/embryo preimplantation genetic diagnosis (PGS/PGD);
• Known past or current thromboembolic disease;
• 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;

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Central Study Contacts

Qingling Yang, Ph.D.

CONTACT

+8666271879; qingling531@163.com

Mengchen Wang, Master

CONTACT

+86 66271879; wmc13949362871@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Fellow

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 30, 2025
• Study Start: May 5, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share