The Effect of VitC on IVF Outcome of DOR Patients

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.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 20-45 who are planning to undergo IVF/ICSI-ET assisted reproductive treatment for infertility.
* At least two of the following DOR diagnostic criteria must be met: baseline FSH: 10 IU/L ≤ FSH \< 20 IU/L; AMH \< 1.1 ng/ml; bilateral ovarian AFC \< 7.
* History of previous IVF/ICSI-ET not exceeding once.
* Patients who can be consistently followed up at this clinic.
* Those who sign an informed consent form and can participate in regular follow-ups.

Exclusion Criteria:

* Decreased ovarian reserve function due to TUNER (X deficiency) syndrome and genetic mutations;
* Diminished ovarian reserve (DOR) due to ovarian surgery or cancer chemotherapy;
* Individuals with severe endocrine system diseases (diabetes, thyroid diseases), digestive system diseases (affecting vitamin C absorption), cardiovascular diseases, renal insufficiency, neurological disorders such as dementia or epilepsy; those infected with HIV, hepatitis, tuberculosis, or other infectious diseases; individuals with severe autoimmune diseases;
* Women who are pregnant, breastfeeding, or have reached menopause;
* Ongoing alcohol or drug abuse, with avoidance of excessive alcohol consumption to prevent adverse reactions;
* Allergies to any component of vitamin C or its formulations;
* Patients currently on high-dose vitamin C supplementation (greater than 500mg/day);
* Individuals with any mental or psychiatric disorders requiring medication, including those with epilepsy or undergoing anti-epileptic treatment; those using antidepressants, etc.;
* Individuals with infectious diseases such as active hepatitis B, active tuberculosis, or AIDS;
* Individuals with other conditions that may cause abnormal ovulation (such as polycystic ovary syndrome, Cushing's syndrome, atypical congenital adrenal hyperplasia, tumors secreting androgens from the ovaries or adrenal glands, thyroid disorders, hyperprolactinemia, etc.);
* Those who have participated in other clinical intervention programs for DOR;
* Individuals unwilling or who have ceased taking supplements not provided by this program.