NCT06794047 The Effect of VitC on IVF Outcome of DOR Patients
| NCT ID | NCT06794047 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University Third Hospital |
| Condition | Diminished Ovarian Reserve |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,100 participants |
| Start Date | 2025-03-17 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,100 participants in total. It began in 2025-03-17 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In the context of the accelerating aging population and the continuous decline in birth rates nationwide, delaying reproductive aging in women and protecting the fertility of women of childbearing age have become urgent issues and key demands that need to be addressed in the field of maternal and child health in China. The ovaries have reproductive and hormone secretion functions and are crucial throughout the female reproductive lifecycle. Women of childbearing age in China face a serious problem of diminished ovarian reserve (DOR), which can lead to infertility, failed in vitro fertilization (IVF) treatments, miscarriage, and other adverse pregnancy outcomes, severely affecting the safety of women and their offspring. For DOR patients who desire to conceive, failure to intervene and treat promptly can result in irreversible losses and impose a significant psychological burden on them. However, there are currently no clear and reliable interventions that can improve ovarian function and enhance fertility in women with DOR. Therefore, exploring new, safe, and patient-acceptable intervention strategies is urgently needed, as it may bring hope and light to women with DOR. Nutrient supplementation, especially vitamin supplementation, has received increasing attention in disease treatment due to its safety, bioavailability, and effectiveness. Previous studies have shown that vitamin C may play an important role in treating diminished ovarian reserve. However, its effects on ovarian function need to be validated in the population. Based on the above research background, this project will conduct a randomized, placebo-controlled, double-blind, multicenter trial. The study subjects will be DOR infertility patients undergoing IVF/ICSI treatment. The intervention group will receive oral vitamin C supplementation at a dosage of 500 mg per dose, twice a day; the control group will receive a placebo with the same dosage and method for at least three months. Patients will be followed up until delivery outcomes, comparing the IVF/ICSI treatment results between the vitamin C supplementation group and the placebo group. The primary endpoint of this clinical trial is the live birth rate of the IVF/ICSI treatment cycle. Secondary endpoints include indicators of improved ovarian reserve function, ovarian aging molecular clocks, IVF-embryo culture indicators, pregnancy rates, pregnancy complications, and neonatal conditions, thereby providing new clues and theoretical basis for clinical treatment plans for DOR patients.
Eligibility Criteria
Definition of DOR: Currently, there is no internationally unified standard for DOR. According to the latest POSEIDON criteria for diminished ovarian reserve (DOR), serum AMH \<1.20 ng/mL or bilateral antral follicle count (AFC) \<5 is classified as DOR. In this study, the participants are primarily DOR patients, with the following inclusion criteria: * Infertile women undergoing their 1st or 2nd IVF treatment * Diagnosed with DOR: POSEIDON criteria (AMH \<1.2 ng/mL or bilateral AFC \<5) BMI between 18.5-28.0 kg/m² * Signed informed consent Exclusion Criteria：Participants meeting any of the following criteria will be excluded from the trial: * PGT (preimplantation genetic testing) candidates * DOR caused by ovarian surgery, cancer radiotherapy/chemotherapy * Other ovulation disorders (e.g., PCOS, Cushing's syndrome, non-classic congenital adrenal hyperplasia, hyperprolactinemia) or endometriosis (chocolate cysts) * Severe thyroid disorders: Hyperthyroidism, Graves' disease, Hashimoto's thyroiditis * Acute/chronic renal insufficiency, hemodialysis, or history of severe kidney impairment * Infectious diseases: HIV, active hepatitis, metabolic acidosis, tuberculosis, etc. * Severe autoimmune diseases (e.g., rheumatoid arthritis, lupus, Crohn's disease) * Cardiovascular events within the past 3 months: Coronary artery disease/myocardial infarction/clinically significant congestive heart failure；Stroke/transient ischemic attack (TIA)；Deep vein thrombosis/pulmonary embolism；Poorly controlled hypertension (SBP ≥160 mmHg or DBP ≥90 mmHg)；Diagnosed diabetes mellitus；Coronary intervention (PCI) or coronary artery bypass grafting (CABG)； * Neurological disorders (e.g., dementia,Alzheimer's, Parkinson's) or use of related medications * Psychiatric disorders or use of antiepileptic/antidepressant drugs * History of cancer or radiotherapy/chemotherapy * Allergy to vitamin C * Current high-dose vitamin C supplementation (\>500 mg/day) * Unwillingness to take the study-provided supplements * Alcohol abuse, smoking, or drug addiction * Participation in other clinical trials within the past month
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06794047 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 45 Years, studying Diminished Ovarian Reserve. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06794047 currently recruiting?
Yes, NCT06794047 is actively recruiting participants. Contact the research team at tiantianpku@126.com for enrollment information.
Where is the NCT06794047 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Shijiazhuang, China, Yinchuan, China and 2 additional locations.
Who is sponsoring the NCT06794047 clinical trial?
NCT06794047 is sponsored by Peking University Third Hospital. The trial plans to enroll 1,100 participants.