The Effect of VitC on IVF Outcome of DOR Patients

NCT06794047 | Recruiting DMC

• 2 other identifiers: M2024646No2024
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 6

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.

Conditions

Diminished Ovarian Reserve; IVF Outcomes

Keywords

vitamin C; IVF outcomes; livebirth; diminished ovarian reserve

Outcome Measures

Primary Outcomes (1)

• Live birth rate

  The main outcome of this trial is the live birth resulting from a sustained pregnancy after the first embryo transfer within 6 months for patients undergoing fresh transfer cycles or frozen embryo cycles. Live birth rate (%) = Number of subjects with live births in each group / Total number of subjects in each group × 100%.

  1 year after oocyte retrieval following embryo transfer

Secondary Outcomes (30)

• Cumulative live birth rate

  1 year after oocyte retrieval following embryo transfer

• Singleton live birth rate

  1year after oocyte retrieval following embryo transfer

• Twin live birth rate

  1 year after oocyte retrieval following embryo transfer

• Clinical pregnancy rate

  28-30 days after embryo transfer

• Ongoing pregnancy

  12 weeks after embryo transfer.

Study Arms (2)

VitC

EXPERIMENTAL

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

Dietary Supplement: Vitamin C

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Vitamin C DIETARY_SUPPLEMENT

Vitamin C tablets, please instruct the patient to swallow with water, 500mg twice daily, morning and evening.

Also known as: VitC, VC, Ascorbic acid

VitC

Placebo OTHER

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

Also known as: control

Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Beijing Obstetrics and Gynecology Hospital: collaborator
• Peking University Shenzhen Hospital: collaborator
• Tang-Du Hospital: collaborator
• General Hospital of Ningxia Medical University: collaborator
• The Second Hospital of Hebei Medical University: collaborator

Study Sites (6)

Beijing Obstetrics and Gynecology Hospital,Capital Medical University

Beijing, Beijing Municipality, 100026, China

RECRUITING

Peking university third hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

The second hospital of Hebei Medical University

Shijiazhuang, Hebei, 050061, China

RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

RECRUITING

Tang Du Hospital

Xi’an, Shanxi, 710038, China

RECRUITING

Peking University Shenzhen Hospital

Shenzhen, Shenzhen, 518036, China

RECRUITING

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Central Study Contacts

Tian Tian, Ph.D

CONTACT

+86 01082266355; tiantianpku@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: During the entire implementation of the RCT, a double-blind design was employed for both the study subjects and researchers. Group allocation concealment was applied to study subjects, clinical practitioners involved in the RCT, outcome observers and assessors, and subsequent data analysts. The pharmaceutical company assigned numbers and labels to the drugs, and when study subjects were enrolled, they were assigned the corresponding drug number. The specific group corresponding to the number remained concealed from the project researchers, participants, and study subjects, with the blind data kept by independent personnel. 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 27, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)