Actively Recruiting
The Effect of Vitamin C Supplementation on Assisted Reproductive Pregnancy Outcomes in Patients With Diminished Ovarian Reserve: A Multicenter, Double-blind, Randomized Controlled Trial
Led by Peking University Third Hospital · Updated on 2025-06-17
1100
Participants Needed
6
Research Sites
52 weeks
Total Duration
On this page
Sponsors
P
Peking University Third Hospital
Lead Sponsor
B
Beijing Obstetrics and Gynecology Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of vitamin C supplementation on women with diminished ovarian reserve (DOR) undergoing IVF/ICSI treatment. DOR can lead to infertility, miscarriage, and failed IVF cycles, significantly affecting women's reproductive health and psychological well-being. Since there are currently no clear treatments to improve ovarian function in DOR patients, this study explores vitamin C as a potentially safe and effective intervention. Participants will be randomly assigned to receive either vitamin C tablets at 500 mg twice daily or matching placebo tablets for at least three months. This is a double-blind, multicenter trial comparing the live birth rates and other reproductive outcomes between the vitamin C and placebo groups. The study will continue follow-up until delivery outcomes to assess pregnancy success and related health indicators. Throughout the study, participants will undergo IVF/ICSI treatments and regular monitoring of ovarian function and pregnancy status. Researchers will collect data on live birth rates, pregnancy complications, embryo quality, and neonatal health. Safety will be monitored for potential vitamin C side effects such as abdominal pain, diarrhea, hyperuricemia, kidney stones, and hemolysis. The total participation period includes treatment and follow-up up to one year after oocyte retrieval.
CONDITIONS
Brief Title
The Effect of VitC on IVF Outcome of DOR Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 20 to 45 years
- Diagnosed with diminished ovarian reserve (AMH <1.2 ng/mL or bilateral antral follicle count <5) according to POSEIDON criteria
- Infertile women undergoing their first or second IVF treatment
- Body mass index (BMI) between 18.5 and 28.0 kg/m²
- Signed informed consent to participate in the study
You will not qualify if you...
- Candidates for preimplantation genetic testing (PGT)
- DOR caused by ovarian surgery, cancer radiotherapy, or chemotherapy
- Other ovulation disorders such as PCOS, Cushing's syndrome, non-classic congenital adrenal hyperplasia, hyperprolactinemia, or endometriosis (chocolate cysts)
- Severe thyroid disorders including hyperthyroidism, Graves' disease, or Hashimoto's thyroiditis
- Acute or chronic kidney failure, hemodialysis, or history of severe kidney impairment
- Infectious diseases such as HIV, active hepatitis, metabolic acidosis, or tuberculosis
- Severe autoimmune diseases like rheumatoid arthritis, lupus, or Crohn's disease
- Cardiovascular events in the past 3 months including coronary artery disease, stroke, deep vein thrombosis, poorly controlled hypertension, diabetes, or coronary interventions
- Neurological disorders or use of related medications
- Psychiatric disorders or use of antiepileptic or antidepressant drugs
- History of cancer, radiotherapy, or chemotherapy
- Allergy to vitamin C
- Current high-dose vitamin C supplementation above 500 mg per day
- Unwillingness to take study supplements
- Alcohol abuse, smoking, or drug addiction
- Participation in other clinical trials within the past month
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment until embryo transfer and pregnancy assessment
Participants take vitamin C tablets or placebo twice daily as part of their IVF treatment.
Multiple visits around IVF procedures including oocyte retrieval and embryo transfer
Duration - Up to 1 year after oocyte retrieval following embryo transfer
Participants are monitored for pregnancy outcomes and possible side effects of vitamin C for up to 1 year after oocyte retrieval following embryo transfer.
Visits for pregnancy checks and outcome assessments up to 1 year
Trial Site Locations
Total: 6 locations
1
Beijing Obstetrics and Gynecology Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100026
Actively Recruiting
2
Peking university third hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
3
The second hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050061
Actively Recruiting
4
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China, 750004
Actively Recruiting
5
Tang Du Hospital
Xi’an, Shanxi, China, 710038
Actively Recruiting
6
Peking University Shenzhen Hospital
Shenzhen, Shenzhen, China, 518036
Actively Recruiting
Research Team
T
Tian Tian, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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