Therapeutic Effect of Vitamin C Supplementation in Patients With Ovarian Aging
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorPeking University Third Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Vitamin C (Ascorbic Acid)
Dietary supplementParticipants swallow synthetic vitamin C tablets 500mg with water, twice a day.
Vitamin C (Ascorbic Acid)
Dietary supplementParticipants swallow naturral vitamin C tablets 500mg with water, twice a day.
Placebo
Other interventionParticipants swallow tablets with the same texture, flavor, and appearance as the experimental group 500mg with water, twice a day.
Treatment groups
354 Participants
are divided into 3 treatment groupsGroup A: Synthetic vitamin CExperimental treatment 1 intervention
Group B: Natural vitamin CExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
1 yearSecondary outcomes
1
FSH level
Follicle-stimulating hormone (FSH): Test the blood FSH level of women.
Time frame
1 year2
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.
Time frame
12 months3
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.
Time frame
12 months4
Clinical pregnancy rate
A clinical pregnancy is a pregnancy that is confirmed by ultrasound.
Time frame
12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: