Therapeutic Effect of Vitamin C Supplementation in Patients With Ovarian Aging

Peking University

Status: Not yet enrolling

Conditions: Ovarian Reserve Function; Premature Ovarian Insufficiency

Treatments: Dietary Supplement: Vitamin C (Ascorbic Acid); Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06794060

M2024647

Details and patient eligibility

About

The goal of this clinical trial is to learn if Vitamin C works to improve ovarian reserve in women with ovarian aging. It will also learn about the safety of Vitamin C. The main questions it aims to answer are:

• Does Vitamin C supplementation improve the ovarian reserve prediction score?
• What medical problems do participants have when taking Vitamin C supplementation?

Researchers will compare Vitamin C to a placebo (a look-alike substance that contains no drug) to see if drug Vitamin C works to improve ovarian reserve in women with ovarian aging. Participants will:

• Take Vitamin C or a placebo every day for 12 months
• Visit the clinic once every 4 weeks for follow-up and drug distribution.
• Return the Vitamin C box at each visit.
• Report any adverse effects of treatment to the doctor.
• Fill out a questionnaire at each visit.
• After 6 months and 12 months of intervention, take blood test and ultrasonic examination.

Enrollment: 354 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Regularity of menstruation changed for less than one year.
• 10U/L≤ FSH<25 U/L in two tests more than 4weeks aprt.
• AMH < 1.1 ng/mL.
• Bilateral ovarian AFC <7.
• Signed informed consent and can participate in regular follow-ups.

Exclusion criteria

• Ovarian aging caused by TUNER (X deletion) syndrome or gene mutation.
• Ovarian aging caused by ovarian surgery or chemotherapy.
• Patients with severe endocrine system diseases (diabetes, thyroid disease), digestive system diseases (affecting VC absorption), cardiovascular system diseases, renal insufficiency (abnormal urine, imaging diagnosis, blood, pathological analysis confirms that kidney damage does exist, or glomerular filtration rate GFR <60mL/min), nervous system diseases such as dementia and epilepsy; patients with infectious diseases such as HIV, hepatitis, tuberculosis; patients with severe autoimmune diseases.
• Continuous alcohol or drug abuse (to avoid adverse reactions caused by drinking).
• Allergic to vitamin C or any component of the preparation.
• Patients who have already started large-dose (greater than 500mg/day) vitamin C supplementation.
• Unwilling to or stop taking supplements not provided by this project.
• Those who have participated in other ovarian aging clinical intervention projects.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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354 participants in 3 patient groups, including a placebo group

Synthetic vitamin C

Experimental group

Description:

Participants will take the synthetic vitamin C twice a day, 500mg per time.

Treatment:

Dietary Supplement: Vitamin C (Ascorbic Acid)

Dietary Supplement: Vitamin C (Ascorbic Acid)

Natural vitamin C

Experimental group

Description:

Participants will take the natural vitamin C twice a day, 500mg per time.

Treatment:

Dietary Supplement: Vitamin C (Ascorbic Acid)

Dietary Supplement: Vitamin C (Ascorbic Acid)

Placebo

Placebo Comparator group

Description:

Participants will take tablets with the same texture, flavor, and appearance as the experimental group twice a day, 500mg per time.

Treatment:

Other: Placebo