Clinical trial NCT06794060: Therapeutic Effect of Vitamin C Supplementation in Patients with Ovarian Aging
Official title: Therapeutic Effect of Vitamin C Supplementation in Patients with Ovarian Aging：a Multicenter, Double-blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Premature Ovarian Insufficiency
Ovarian Reserve Function
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 354
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: ovarian reserve prediction score
timeFrame: 1 year
Secondary outcomes:
measure: FSH level
timeFrame: 1 year
measure: AMH level
timeFrame: 12 months
measure: AFC
timeFrame: 12 months
measure: Clinical pregnancy rate
timeFrame: 12 months
measure: Time to pregnancy
timeFrame: 12 months
measure: Livebirth rate
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: