A Randomized and Double-blind Clinical Trial of Jiajian Guishen Granules on the Modulation of Ovarian Function in Patients With Poor Ovarian Response
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Anti-Miller's Tube Hormone（AMH）
研究概览
简要总结
Relying on the Department of Gynecology of Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine and chaoyang hospital of Capital medical university, this randomized controlled clinical study was carried out to investigate the application of kidney tonifying herbs to patients with poor ovarian response（POR）.
A total of 76 patients with POR were collected and stratified district groups were randomly divided into a test group and a control group, with 38 patients included in each group. The experimental group was intervented with JJGS granules + coenzyme Q10 simulant, and the control group was intervened with coenzyme Q10 + JJGS granules simulant. AMH, serum basal sex hormone, AFC, TCM syndrome score, modified Kupperman scale and pregnancy status were observed before and after treatment to investigate the effects of Jiajian Guishen granules on the ovarian function of POR patients.
详细描述
This study was a multicenter, stratified block randomized, double-blind, double simulation, positive controlled clinical trial.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman who meet the diagnostic criteria for poor ovarian response;
- •Woman who meet the TCM diagnostic criteria for kidney deficiency;
- •Woman whose serum basal FSH(two consecutive menstrual cycles)between 10-25mIU/mL
- •Woman whose AMH <1.1ng/ml;
- •Woman aged ranged from 20-45 years old
- •Woman whose body mass index (BMI)<35 kg/m2
- •Womanwho voluntarily signed the informed consent form.
排除标准
- •Woman who have combination of serious diseases such as cardiovascular, cerebrovascular, hepatic, renal and hematopoietic systems, and malignant tumors;
- •Woman who have other endocrine diseases, such as polycystic ovary syndrome and hyperprolactinemia;
- •Woman who are unable to cooperate with the treatment and follow-up, such as combined neurological and psychiatric disorders, or those who are unwilling to cooperate.
- •Woman who have used the same efficacy of herbs or other therapies in the last 1 month;
- •Woman who are allergic to the drugs used in this study.
研究组 & 干预措施
Jiajian Guishen granules group
Jiajian Guishen granules + coenzyme Q10 simulant
干预措施: Jiajian Guishen granules (Drug)
coenzyme Q10 group
Jiajian Guishen granules simulant+ coenzyme Q10
干预措施: coenzyme Q10 (Drug)
结局指标
主要结局
Anti-Miller's Tube Hormone（AMH）
时间窗: before treatment and the first menstrual period 2-4 days after treatment
The unit is ng/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, anti-mullerian hormone (AMH) was measured by radioimmunoassay
次要结局
- Follicle-stimulating hormone（FSH）(before treatment and the first menstrual period 2-4 days after treatment)
- Progesterone (P)(before treatment and the first menstrual period 2-4 days after treatment)
- Testosterone（T）(before treatment and the first menstrual period 2-4 days after treatment)
- Estrogen (E2)(before treatment and the first menstrual period 2-4 days after treatment)
- antral follicle count（AFC）(before treatment and early follicular phase in the first post-treatment menstrual cycle day 1)
- Luteinizing hormone（LH）(before treatment and the first menstrual period 2-4 days after treatment)
- Traditional Chinese Medicine Score(baseline and immediately after treatment)
- Modified Kupperman rating scale(baseline and immediately after treatment)
- Clinical pregnancy rate(up to 6 months)
- Early miscarriage rate(up to 6 months)
研究者
Shi Yun
Chief of Gynecology
Dongzhimen Hospital, Beijing