Therapeutic Effect of Vitamin C Supplementation in Patients With Ovarian Aging

Therapeutic Effect of Vitamin C Supplementation in Patients With Ovarian Aging：a Multicenter, Double-blind, Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Premature Ovarian Insufficiency; Ovarian Reserve Function
• Intervention / Treatment: Other: Placebo; Dietary supplement: Vitamin C (Ascorbic Acid); Dietary supplement: Vitamin C (Ascorbic Acid)

• Study Type: Interventional
• Enrollment (Estimated): 354
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tian Tian; Phone Number: +8601082266355; Email: tiantianpku@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will take tablets with the same texture, flavor, and appearance as the experimental group twice a day, 500mg per time.	Other: Placebo; Participants swallow tablets with the same texture, flavor, and appearance as the experimental group 500mg with water, twice a day.
Experimental: Synthetic vitamin C; Participants will take the synthetic vitamin C twice a day, 500mg per time.	Dietary supplement: Vitamin C (Ascorbic Acid); Participants swallow synthetic vitamin C tablets 500mg with water, twice a day.; Dietary supplement: Vitamin C (Ascorbic Acid); Participants swallow naturral vitamin C tablets 500mg with water, twice a day.
Experimental: Natural vitamin C; Participants will take the natural vitamin C twice a day, 500mg per time.	Dietary supplement: Vitamin C (Ascorbic Acid); Participants swallow synthetic vitamin C tablets 500mg with water, twice a day.; Dietary supplement: Vitamin C (Ascorbic Acid); Participants swallow naturral vitamin C tablets 500mg with water, twice a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ovarian reserve prediction score	The ovarian reserve prediction score was calculated using the Ovarian Reserve Prediction Tool, OvaRePred. This tool evaluates the current ovarian reserve status and predicts the future age at which diminished ovarian reserve (DOR) and perimenopause may occur. The score ranges from 0 to 100, with higher scores indicating better ovarian function.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FSH level	Follicle-stimulating hormone (FSH): Test the blood FSH level of women.	1 year
AMH level	Anti-Müllerian Hormone (AMH) is a hormone produced by the granulosa cells of ovarian follicles. It serves as a key indicator of a woman's ovarian reserve, which refers to the number of viable eggs remaining in the ovaries.	12 months
AFC	Antral Follicle Count (AFC), is a measure used in reproductive medicine to assess a woman's ovarian reserve, that can be seen and counted via transvaginal ultrasound.	12 months
Clinical pregnancy rate	A clinical pregnancy is a pregnancy that is confirmed by ultrasound.	12 months
Time to pregnancy	Time to pregnancy (TTP) refers to the duration it takes for a couple to conceive, starting from the time they begin trying to achieve a pregnancy.	12 months
Livebirth rate	A live birth refers to the delivery of a baby who shows any signs of life after being born, regardless of the pregnancy's duration.	12 months

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 2, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): January 27, 2025

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Menopause, Premature; Primary Ovarian Insufficiency; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Micronutrients; Antioxidants; Protective Agents; Ascorbic Acid; Vitamins
• Other Study ID Numbers: M2024647

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We have decided not to share the IPD from this study due to concerns about participant privacy and confidentiality. Despite efforts to de-identify the data, there remains a risk of re-identification, which could compromise the privacy of the participants involved. Additionally, there are legal and ethical considerations that restrict the sharing of sensitive health information without explicit consent from the participants. Furthermore, the resources required to prepare and manage the data for external sharing are currently beyond our capacity. Therefore, to ensure the protection of our participants and comply with ethical standards, we have opted not to share the IPD at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No