The Effect of VitC on IVF Outcome of DOR Patients (DORIVF-VC)

Peking University

Status: Enrolling

Conditions: IVF Outcomes; Diminished Ovarian Reserve

Treatments: Other: Placebo; Dietary Supplement: Vitamin C

Study type: Interventional

Funder types: Other

Identifiers

NCT06794047

M2024646

No2024 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 1,100 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,100 participants in 2 patient groups, including a placebo group

VitC

Experimental group

Description:

The women will intake the vitamin C twice a day, 500mg per time.

Treatment:

Dietary Supplement: Vitamin C

Placebo

Placebo Comparator group

Description:

Tablets with the same material, flavor, and appearance as the intervention group.

Treatment:

Other: Placebo