Therapeutic Effect of Vitamin C Supplementation in Patients With Ovarian Aging：a Multicenter, Double-blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 354
- 主要终点
- ovarian reserve prediction score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 <
- •Signed informed consent and can participate in regular follow-ups.
排除标准
- •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.
研究组 & 干预措施
Synthetic vitamin C
Participants will take the synthetic vitamin C twice a day, 500mg per time.
干预措施: Vitamin C (Ascorbic Acid) (Dietary Supplement)
Natural vitamin C
Participants will take the natural vitamin C twice a day, 500mg per time.
干预措施: Vitamin C (Ascorbic Acid) (Dietary Supplement)
Placebo
Participants will take tablets with the same texture, flavor, and appearance as the experimental group twice a day, 500mg per time.
干预措施: Placebo (Other)
结局指标
主要结局
ovarian reserve prediction score
时间窗: 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.
次要结局
- Time to pregnancy(12 months)
- FSH level(1 year)
- Clinical pregnancy rate(12 months)
- AMH level(12 months)
- AFC(12 months)
- Livebirth rate(12 months)
研究者
Jie Qiao
Professor
Peking University Third Hospital