Ovarian Reserve Function, Premature Ovarian Insufficiency
Conditions
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.
Interventions
DIETARY_SUPPLEMENTVitamin C (Ascorbic Acid)
Participants swallow synthetic vitamin C tablets 500mg with water, twice a day.
OTHERPlacebo
Participants swallow tablets with the same texture, flavor, and appearance as the experimental group 500mg with water, twice a day.
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
A double-blind design was employed for researchers were designed to be blinded. Allocation concealment was designed to apply to study subjects, clinical practitioners, outcome assessors and subsequent data analysts. The pharmaceutical company assigned numbers and labels to the drugs, and when study subjects were enrolled, they were assigned the corresponding drug number. The specific group corresponding to the number remained concealed from the project researchers, participants, and study subjects, with the blind data kept by independent personnel. After the follow-up, independent personnel who maintained the blind data provided group information to the data analysts. The synthetic vitamin C, natural vitamin C and control groups were still represented as A, B and C, concealing the specific identities of the ABC groups from the data analysts. After the data comparison between the two groups the unblinding of the AB groups was conducted.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ovarian reserve prediction score | 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
| Measure | Time frame | Description |
|---|---|---|
| AMH level | 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. |
| AFC | 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. |
| FSH level | 1 year | Follicle-stimulating hormone (FSH): Test the blood FSH level of women. |
| Time to pregnancy | 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. |
| Livebirth rate | 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. |
| Clinical pregnancy rate | 12 months | A clinical pregnancy is a pregnancy that is confirmed by ultrasound. |
Contacts
Primary ContactTian Tian
Outcome results
None listed