Menu
Not yet recruiting NCT06794060

Therapeutic Effect of Vitamin C Supplementation in Patients With Ovarian Aging

No phase Interventional Premature Ovarian Insufficiency Ovarian Reserve Function

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vitamin C (Ascorbic Acid), Vitamin C (Ascorbic Acid), Placebo.
Who it may be relevant to
Registry conditions: Premature Ovarian Insufficiency, Ovarian Reserve Function. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • ovarian reserve prediction score [Time frame: 1 year]
Secondary outcome measures (6)
  • FSH level [Time frame: 1 year]
  • AMH level [Time frame: 12 months]
  • AFC [Time frame: 12 months]
  • Clinical pregnancy rate [Time frame: 12 months]
  • Time to pregnancy [Time frame: 12 months]
  • Livebirth rate [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06794060 · M2024647

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗