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NCT Number: NCT06950736

NR vs. Vitamin E in Enhancing Fertility

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.

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Key information

Conditions

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

Age range

35 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

Patients received daily oral supplementation of either nicotinamide riboside (NR, 600 mg/day) or vitamin E (200 mg/day) for two consecutive months, initiated on day 2 of the menstrual cycle. Participants were enrolled if they planned to undergo in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) with a gonadotropin-releasing hormone (GnRH) antagonist protocol following the intervention period.

Biological Samples

Peripheral blood mononuclear cells (PBMC) were isolated from venous blood.

Follicular fluid containing granulosa cells and discarded oocytes were collected during routine oocyte retrieval procedures.

Hormonal and Ovarian Assessments

Baseline 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.

Post-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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infertile women aged between 35 and 42 years;
  • 0.1 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.

Exclusion criteria

  • 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;
  • Patients with contraindications or allergic history to the use of GnRH-a, r-hFSH, hCGα, progesterone;
  • Those who are addicted to alcohol, tobacco, drugs or drug abuse;
  • Being exposed to teratogenic amounts of radiation, poisons and drugs and in the action period;
  • 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;
  • Persons who are HIV or syphilis positive;
  • Those with positive serum pregnancy tests;
  • 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;
  • Participants who had participated in other clinical trials within 3 months prior to screening.

Treatment and study plan

NR

Dietary Supplement

600 mg/d of oral NR for two months

Vit E

Dietary Supplement

200 mg/d of oral Vitamin E for two months

Primary outcomes

  1. Follicle Counting

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

    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.

  2. Serum AMH Levels

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

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

  3. Serum FSH Levels

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

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

  4. ART outcomes assessed by the number of clinically viable embryos and clinical pregnancy rates

    Time frame: From embryo transfer to the 14-day post-transfer clinical observation period

    number of top-quality day 3 embryos and transferable embryos ；the blastocyst formation rate；the number of clinically usable embryos；clinical pregnancy rates

  5. Serum LH Levels

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

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

  6. Serum P Levels

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

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

  7. Serum E2 Levels

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

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

  8. Serum Testosterone levels

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

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

  9. Antral Follicle Count Retrived

    Time frame: Immedietly after oocyte 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.

  10. Oocytes Retrived

    Time frame: Immedietly after oocyte retrived

    Number of oocytes retrieved in Antagonist Protocol

  11. NAD+ Levels in PBMCs

    Time frame: 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 and NAD+/NADH in PBMCs before and after medication

  12. NAD+ Levels in GCs

    Time frame: Immedietly after oocyte retrived

    NAD+ levels and NAD+/NADH in GCs

  13. Number of Day 3 embryos

    Time frame: Day 3 of Embryo Culture

    Number of Day 3 embryos

  14. Number of Day 3 top-quality embryos

    Time frame: Day 3 of Embryo Culture

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

  15. Number of transferable embryos

    Time frame: Day 3 of Embryo Culture

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

  16. Blastocyst Formation Rate

    Time frame: Day 6 of Embryo Culture

    Blastocyst Formation Rate (BFR) = (Number of embryos reaching blastocyst stage ÷ Total embryos cultured to Day 5-6) × 100%

Study contacts

Contact information is provided by the study sponsor or research team.

Mengchen Wang, Master

CONTACT

[email protected]

+86 66271879

Qingling Yang, Ph.D.

CONTACT

[email protected]

+8666271879

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Zhengzhou University

Other

Registry information

Official study title

Nicotinamide Riboside vs. Vitamin E for Enhancing Fertility in Advanced Maternal Age: A Randomized Parallel Trial

Acronym: NRVEERSAAM

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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