NR vs. Vitamin E in Enhancing Fertility

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35-42
SponsorThe First Affiliated Hospital of Zhengzhou University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

Adenomyosis and uterine fibroids compression of uterine uterine line;

Untreated bilateral hydrosalpinx;

Uncured endometrial disease;

Any pregnancy occurred within 3 months before screening;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: NRExperimental treatment 1 intervention
Group B: Vit EExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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