Electroacupuncture for Diminished Ovarian Reserve-a Cohort Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 主要终点
- change of FSH from baseline
研究概览
简要总结
Diminished ovarian reserve (DOR)is a disease can not be cured. Medicine for DOR includes dehydroepiandrosterone (DHEA), hormone replacement therapy (HRT), immunosuppressive agents and alternative therapy, etc. Electroacupuncture (EA) can help patients regain regular menses, increase the estradiol (E2) level and decrease the follicle-stimulating hormone (FSH) and decrease FSH/luteotropic (LH) ratio. In this cohort study, we aim to observe the effect of EA versus other therapies for DOR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age younger than 40 yr
- •10IU/L ≤ FSH ≤ 40IU/L
- •Volunteer to join the research and give the informed consent
排除标准
- •A history of ovariectomy, receiving cytotoxic chemotherapy or irradiation
- •Reproductive system infection or tumor
- •Autoimmune disease
- •Amenorrhea due to reproduction abnormality or pregnancy
- •Patients can not adhere to treatment due to personal situation
- •Patients have taken immunosuppressive agents in past 6 months
- •receive treatment for less than 1 week before withdrawal
研究组 & 干预措施
EA group
Patients choose this group will receive EA as a combination. Beside of EA, participants could receive oral medicine as the same as that of the drug group. The EA regimen has two point formulae, i.e. A (BL33) and B (ST25, EX-CA1 and RN4). The two formulae will be used alternatively. One session will last for 20 minutes, 5 sessions per week for the first 4 weeks and 3 sessions per week later (44 sessions in all).
干预措施: EA (Other)
EA group
Patients choose this group will receive EA as a combination. Beside of EA, participants could receive oral medicine as the same as that of the drug group. The EA regimen has two point formulae, i.e. A (BL33) and B (ST25, EX-CA1 and RN4). The two formulae will be used alternatively. One session will last for 20 minutes, 5 sessions per week for the first 4 weeks and 3 sessions per week later (44 sessions in all).
干预措施: HRT, DHEA and herb (Drug)
drug group
Hormone replacement therapy (HRT), DHEA and herb decoction are allowed to be used for this group. Treatment course is not fixed. Immunosuppressive agents are not allowed.
干预措施: HRT, DHEA and herb (Drug)
结局指标
主要结局
change of FSH from baseline
时间窗: baseline, week 12
The follicle-stimulating hormone (FSH) will be tested at baseline and week 12
次要结局
- change of FSH level from baseline(baseline, week 4, 8, 16, 20, and 24)
- changes in FSH/LH ratio, LH, and E2 from baseline(baseline, week 4, 8, 12, 16, 20, and 24)
- change of symptom scale(baseline, week 12, week 24)
- proportion of patients regaining regular menses(baseline, weeks 8, 12 and 24)
研究者
Liu Zhishun
Dean of Acupuncture Department of Guangan'men Hospital
Guang'anmen Hospital of China Academy of Chinese Medical Sciences