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NCT Number: NCT06794060

Therapeutic Effect of Vitamin C Supplementation in Patients With Ovarian Aging

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.

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Key information

Conditions

Premature Ovarian Insufficiency Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Ovarian Reserve Function Primary Ovarian Insufficiency Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

vitamin C (ascorbic acid)

Dietary Supplement

Participants swallow synthetic vitamin C tablets 500mg with water, twice a day.

Placebo

Other

Participants swallow tablets with the same texture, flavor, and appearance as the experimental group 500mg with water, twice a day.

Primary outcomes

  1. ovarian reserve prediction score

    Time frame: 1 year

    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.

Secondary outcomes

  1. FSH level

    Time frame: 1 year

    Follicle-stimulating hormone (FSH): Test the blood FSH level of women.

  2. AMH level

    Time frame: 12 months

    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.

  3. AFC

    Time frame: 12 months

    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.

  4. Clinical pregnancy rate

    Time frame: 12 months

    A clinical pregnancy is a pregnancy that is confirmed by ultrasound.

  5. Time to pregnancy

    Time frame: 12 months

    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.

  6. Livebirth rate

    Time frame: 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tian Tian

CONTACT

[email protected]

+8601082266355

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Jan 27, 2025
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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