Infertility FemaleNRVEERSAAMNCT06950736
NR vs. Vitamin E in Enhancing Fertility
A study testing NR and Vit E in people with Infertility Female, run by The First Affiliated Hospital of Zhengzhou University.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility Female
- What is being tested?
- NR and Vit E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Nicotinamide Riboside vs. Vitamin E for Enhancing Fertility in Advanced Maternal Age: A Randomized Parallel 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.
Read the 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
- Being tested
- NR, Vit E
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRDietary supplement
600 mg/d of oral NR for two months
Vit EDietary supplement
200 mg/d of oral Vitamin E for two months
| Study group | Role | What they receive |
|---|---|---|
| NR | Experimental | experimental group: 600 mg/d of oral NR, NIAGEN for two months Receives: Dietary Supplement: NR |
| Vit E | Experimental | control group: 200 mg/d of oral Vitamin E for two months Receives: Dietary Supplement: Vit E |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immedietly after oocyte retrived
Oocytes Retrived
Number of oocytes retrieved in Antagonist Protocol
Measured: Immedietly after oocyte retrived
NAD+ Levels in PBMCs
NAD+ levels and NAD+/NADH in PBMCs before and after medication
Measured: 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
Measured: Immedietly after oocyte retrived
Number of Day 3 embryos
Number of Day 3 embryos
Measured: 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
Measured: Day 3 of Embryo Culture
Number of transferable embryos
total number of embryos that meet predefined laboratory criteria for potential implantation
Measured: 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%
Measured: Day 6 of Embryo Culture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start5 May 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility FemaleStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingling Yang, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950736
- Sponsor's protocol ID
- QNCXTD2023017
- Other IDs
- QNCXTD2023017
- Acronym
- NRVEERSAAM
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotinamide Riboside vs. Vitamin E for Enhancing Fertility in Advanced Maternal Age: A Randomized Parallel Trial
- ClinicalTrials.gov ID
- NCT06950736
- Acronym / sponsor ID
- NRVEERSAAM / QNCXTD2023017
- Conditions
- Infertility Female
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 5 May 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NR | Experimental | Dietary Supplement: NRexperimental group: 600 mg/d of oral NR, NIAGEN for two months |
| Vit E | Experimental | Dietary Supplement: Vit Econtrol group: 200 mg/d of oral Vitamin E for two months |
Who may qualify
- Ages
- 35 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NR600 mg/d of oral NR for two months | Dietary supplement | NR |
| Vit E200 mg/d of oral Vitamin E for two months | Dietary supplement | Vit E |
Primary outcome
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.
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.
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.
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
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.
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.
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.
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.
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.
Oocytes Retrived
Time frame: Immedietly after oocyte retrived
Number of oocytes retrieved in Antagonist Protocol
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
NAD+ Levels in GCs
Time frame: Immedietly after oocyte retrived
NAD+ levels and NAD+/NADH in GCs
Number of Day 3 embryos
Time frame: Day 3 of Embryo Culture
Number of Day 3 embryos
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
Number of transferable embryos
Time frame: Day 3 of Embryo Culture
total number of embryos that meet predefined laboratory criteria for potential implantation
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%
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing NR and Vit E in people with Infertility Female, run by The First Affiliated Hospital of Zhengzhou University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingling Yang, Ph.D. (+8666271879, qingling531@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.