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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
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.
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
Serum AMH Levels
Blood samples for AMH were collected on days 2-3 of the menstrual cycle before ovarian stimulation.
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
Serum FSH Levels
Blood samples for FSH were collected on days 2-3 of the menstrual cycle before ovarian stimulation.
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
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
Time frame: 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.
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
Serum P Levels
Blood samples for P were collected on days 2-3 of the menstrual cycle before ovarian stimulation.
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
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Serum E2 Levels
Blood samples for E2 were collected on days 2-3 of the menstrual cycle before ovarian stimulation.
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
Serum Testosterone levels
Blood samples for testosterone were collected on days 2-3 of the menstrual cycle before ovarian stimulation.
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
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.
Time frame: Immedietly after oocyte retrived
Oocytes Retrived
Number of oocytes retrieved in Antagonist Protocol
Time frame: Immedietly after oocyte retrived
NAD+ Levels in PBMCs
NAD+ levels and NAD+/NADH in PBMCs before and after medication
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 in GCs
NAD+ levels and NAD+/NADH in GCs
Time frame: Immedietly after oocyte retrived
Number of Day 3 embryos
Number of Day 3 embryos
Time frame: 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
Time frame: Day 3 of Embryo Culture
Number of transferable embryos
total number of embryos that meet predefined laboratory criteria for potential implantation
Time frame: 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%
Time frame: Day 6 of Embryo Culture