Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1100 participants
INTERVENTIONAL
2025-03-17
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
After the follow-up, independent personnel who maintained the blind data provided group information to the data analysts. The vitamin C and control groups were still represented as A and B, concealing the specific identities of the AB groups from the data analysts. After the data comparison between the two groups the unblinding of the AB groups was conducted.
Study Groups
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VitC
The women will intake the vitamin C twice a day, 500mg per time.
Vitamin C
Vitamin C tablets, please instruct the patient to swallow with water, 500mg twice daily, morning and evening.
Placebo
Tablets with the same material, flavor, and appearance as the intervention group.
Placebo
Tablets with the same material, flavor, and appearance as the intervention group.
Interventions
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Vitamin C
Vitamin C tablets, please instruct the patient to swallow with water, 500mg twice daily, morning and evening.
Placebo
Tablets with the same material, flavor, and appearance as the intervention group.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
45 Years
FEMALE
No
Sponsors
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Beijing Obstetrics and Gynecology Hospital
OTHER
Peking University Shenzhen Hospital
OTHER
Tang-Du Hospital
OTHER
General Hospital of Ningxia Medical University
OTHER
The Second Hospital of Hebei Medical University
OTHER
Peking University Third Hospital
OTHER
Responsible Party
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Jie Qiao
Professor
Locations
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Beijing Obstetrics and Gynecology Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Peking university third hospital
Beijing, Beijing Municipality, China
The second hospital of Hebei Medical University
Shijiazhuang, Hebei, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Tang Du Hospital
Xi’an, Shanxi, China
Peking University Shenzhen Hospital
Shenzhen, Shenzhen, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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No2024
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
M2024646
Identifier Type: -
Identifier Source: org_study_id
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