Vitamin C to improve IVF outcomes for women with diminished ovarian reserve
The Effect of Vitamin C Supplementation on Assisted Reproductive Pregnancy Outcomes in Patients With Diminished Ovarian Reserve: A Multicenter, Double-blind, Randomized Controlled Trial.
This trial will test whether taking vitamin C during IVF improves pregnancy and live-birth chances for women with diminished ovarian reserve.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1100 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Female |
| Sponsor | Peking University Third Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Beijing, Beijing Municipality and 5 other locations) |
| Trial ID | NCT06794047 on ClinicalTrials.gov |
What this trial studies
Participants with diminished ovarian reserve (DOR) who are undergoing their first or second IVF cycle will be given either oral vitamin C or a matching placebo while following standard IVF protocols to see if antioxidant therapy changes outcomes. Eligible women meet POSEIDON DOR criteria (AMH <1.2 ng/mL or bilateral AFC <5) and have BMI 18.5–28 kg/m², while those with prior ovarian surgery– or cancer therapy–related DOR, certain endocrine disorders, endometriosis, or who plan PGT are excluded. Treatments and follow-up occur at collaborating hospitals in Beijing and Hebei, with outcomes tracked from oocyte retrieval through embryo transfer and pregnancy. Primary endpoints include IVF success measures such as live birth, with secondary measures like oocyte yield and clinical pregnancy rate.
Who should consider this trial
Good fit: Infertile women having their first or second IVF cycle who meet POSEIDON criteria for DOR (AMH <1.2 ng/mL or bilateral AFC <5), have BMI 18.5–28 kg/m², and can give informed consent.
Not a fit: Patients whose DOR results from ovarian surgery or cancer therapy, those with PCOS, endometriosis, severe thyroid disorders, PGT candidates, or women outside the BMI range are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, vitamin C could increase the chance of pregnancy and live birth for women with diminished ovarian reserve undergoing IVF.
How similar studies have performed: Previous small trials of antioxidants in IVF have shown mixed and inconclusive results, and vitamin C specifically for improving outcomes in DOR is not yet proven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality and 5 other locations
- Beijing Obstetrics and Gynecology Hospital,Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
- Peking university third hospital — Beijing, Beijing Municipality, China (Recruiting)
- The second hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)
- General Hospital of Ningxia Medical University — Yinchuan, Ningxia, China (Recruiting)
- Tang Du Hospital — Xi’an, Shanxi, China (Recruiting)
- Peking University Shenzhen Hospital — Shenzhen, Shenzhen, China (Recruiting)
Study contacts
- Study coordinator: Tian Tian, Ph.D
- Email: tiantianpku@126.com
- Phone: +86 01082266355
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.