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Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)

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Heilongjiang University of Chinese Medicine

关键词

抽象

This is a multicenter double-blind randomized controlled trial. A total of 420 anovulatory Chinese women with PCOS will be recruited, and the randomization will be stratified by each participating site. Participants will be randomized into one of the two treatment arms: letrozole and CHMG or letrozole and CHMG placebo. CHMG or its placebo will be taken twice a day for up to six months. Letrozole (2.5 mg daily) was given on days 3-7 of the menstrual cycle after a spontaneous period or withdrawal bleeding, and the dose will be increased to 5.0 mg daily during the last three months for non-pregnant women in both groups.The aim of the present study is to determine the efficacy of combined treatment with letrozole and CHMG on improving live birth rates in infertile Chinese women with PCOS. Our hypothesis is that the combination of letrozole and CHMG is more likely to increase the ovulation rate and decrease the miscarriage rate and result in a higher live birth rate in PCOS women than letrozole alone.

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

Polycystic Ovary Syndrome

干预/治疗

Drug: Letrozole

Drug: Letrozole+ Chinese herbal medicine granules

-

手臂组

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
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]

Follicle-stimulating hormone, luteinizing hormone, total testosterone, sex hormone binding globulin, and dehydroepiandrosterone sulphate.

4. Change in metabolic profile [Up to 1 year]

glucose and insulin concentrations, cholesterol, triglycerides, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol.

5. Change in physical measurements [Up to 1 year]

weight, vital signs, and hip and waist measurements.

6. Pregnancy complications [Up to 1 year]

gestational diabetes, pregnancy-induced hypertension, intrauterine growth retardation, ectopic pregnancy, congenital anomaly, preeclampsia, preterm labor, HELLP syndrome, preterm premature rupture of membranes, placental abruption, placenta accreta, placenta previa, postpartum hemorrhage, and others.

7. Birth defects [Up to 1 year]

8. Safety parameters [Up to 1 year]

renal and liver function tests and complete blood count.

9. Side effect profile [Up to 1 year]

The major risks to the subject are side effects from letrozole and CHMG and the risks associated with pregnancy.

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