Effect of Electro-acupuncture on Ovarian Function and Outcome of IVF-ET of Women With Diminished Ovarian Reserve：a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 338
- 试验地点
- 1
- 主要终点
- Assessing the change of ovarian reserve function
研究概览
简要总结
Diminished ovarian reserve (DOR) is the precursor state of ovarian failure, and can cause the decline of women's reproductive function. Some studies have demonstrated that acupuncture can improve ovarian function. In this trial, we hypothesize that electro-acupuncture is efficient for the ovarian function and the following outcome of IVF-ET in DOR patients.
详细描述
First, patients will be recruited according to the inclusion criteria and exclusion criteria.
Second, baseline measurements (including ovarian reserve function, blood biochemical index, scores from the self-rating anxiety and depression scale, quality of life) will be taken.
Third, each patient will receive 24 sessions of acupuncture in 2-3 months, twice or three times a week.
Last, the above baseline measurements will be taken again as soon as the treatment is finished and outcome measures will be recorded after the treatment.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age < 40, will undergo IVF-ET;
- •Low ovarian reserve: Antral follicle count (AFC)<7, or AMH<1.1ng/ml; or has a history of poor ovarian response: in the last hyper stimulation cycle, the number of retrieved oocytes<3;
- •Spouse' semen examination is normal, or after semen prewash can reach the standard of common IVF or Intracytoplasmic Sperm Injection(ICSI).
排除标准
- •Male with azoospermia;
- •Male/female's chromosome is abnormal;
- •Adenomyosis, uterine fibroids, endometrial polyps, scar uterine, reproductive system tuberculosis, oviduct effusion, pelvic lesions such as ovarian endometriosis cyst or tumor;
- •Female has other endocrine disease: thyroid diseases, hyperprolactinemia, insulin resistance, diabetes, adrenal diseases, etc.
- •Definitively diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome;
- •Other pathogenesis that leads to recurrent miscarriage or agnogenic recurrent miscarriage;
- •A history of cancer and has received radiotherapy and chemotherapy;
- •Had acupuncture treatment in recent 3 months;
- •Unwilling to sign the informed consent of this study.
结局指标
主要结局
Assessing the change of ovarian reserve function
时间窗: 0 week and up to 4 weeks
Assessing patients' ovarian reserve function before and after electro-acupuncture intervention, including: (1) The serum AMH, inhibin, and FSH and E2 levels on the third day of menstruation;(2) AFC.
次要结局
- Clinical pregnancy rate(through study completion, an average of 1 year)
- Outcomes of IVF(through study completion, an average of 1 year)
- Blood biochemical index examination(0 week and up to 12 weeks)
- Questionnaires(0 week and up to 4 weeks)
- Follow-up detection(through study completion, an average of 1 year)
研究者
Dongmei Huang
Department of Integrated Traditional Chinese and Western Medicine Tongji hospital Affiliation: Huazhong University of Science and Technology
Huazhong University of Science and Technology