Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)
关键词
抽象
日期
最后验证: | 10/31/2013 |
首次提交: | 09/05/2011 |
提交的预估入学人数: | 09/07/2011 |
首次发布: | 09/08/2011 |
上次提交的更新: | 11/03/2013 |
最近更新发布: | 11/04/2013 |
实际学习开始日期: | 08/31/2009 |
预计主要完成日期: | 07/31/2014 |
预计完成日期: | 07/31/2014 |
状况或疾病
干预/治疗
Drug: Letrozole
Drug: Letrozole+ Chinese herbal medicine granules
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: Letrozole+ Chinese herbal medicine granules | Drug: Letrozole+ Chinese herbal medicine granules twice a day for 6 month |
Placebo Comparator: Letrozole+ Chinese herbal medicine granules placebo |
资格标准
有资格学习的年龄 | 20 Years 至 20 Years |
有资格学习的性别 | Female |
接受健康志愿者 | 是 |
标准 | Inclusion criteria 1. Chinese women with PCOS. PCOS must have been diagnosed based on the presence of two of the following three Rotterdam criteria : (1) oligomenorrhea, anovulation; (2) hyperandrogenism; and (3) the observation of polycystic ovaries by sonography. Oligomenorrhea is defined as an intermenstrual interval >35 days or <8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days. 2. History of at least one year of infertility. 3. Age between 20 and 40 years old. 4. Normal semen analysis based on World Health Organization criteria (2010). The husband did not need to sign the consent form because semen analysis is part of the clinical assessment at the sites. A sperm concentration ≥15 × 106/mL and total motility ≥40% in the semen analysis of the husband was required for the woman to be included. 5. Normal uterine cavity and at least one tube patent upon hysterosalpingography or HyCoSy. Exclusion criteria 1. History of significant system diseases such as heart, lung, or kidney diseases. 2. History of other endocrine disorders. 3. Use of hormonal therapy, including metformin, in the past 3 months. 4. Previous sterilization procedures (vasectomy or tubal ligation) that have been reversed. |
结果
主要结果指标
1. Live birth rate [Up to 2 years]
次要成果指标
1. Ovulation rate [Up to 1 year]
2. Miscarriage rate [Up to 1 year]
3. Change in hormonal profile [Up to 1 year]
4. Change in metabolic profile [Up to 1 year]
5. Change in physical measurements [Up to 1 year]
6. Pregnancy complications [Up to 1 year]
7. Birth defects [Up to 1 year]
8. Safety parameters [Up to 1 year]
9. Side effect profile [Up to 1 year]