NCT06950736

NR vs. Vitamin E in Enhancing Fertility

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: Female
• Age: 35 Years – 42 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Infertility Female

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	NR	600 mg/d of oral NR for two months
DIETARY_SUPPLEMENT	Vit E	200 mg/d of oral Vitamin E for two months

Timeline

• Start date: 2025-05-05
• Primary completion: 2026-04-01
• Completion: 2027-12-01
• First posted: 2025-04-30
• Last updated: 2025-04-30