Status:
NOT_YET_RECRUITING
NR vs. Vitamin E in Enhancing Fertility
Lead Sponsor:
The First Affiliated Hospital of Zhengzhou University
Conditions:
Infertility Female
Eligibility:
FEMALE
35-42 years
Phase:
NA
Brief 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 (or...
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. Participa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06950736
Start Date
May 5 2025
End Date
December 1 2027
Last Update
April 30 2025
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