Symptoms and General Pathology

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

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Syndrome

Infertility

Polycystic Ovary Syndrome

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Genital Diseases, Female

Genital Diseases

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

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Antineoplastic Agents

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Letrozole

Aromatase Inhibitors

Enzyme Inhibitors

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Hormone Antagonists

2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6.

Chinese herbal medicine granules or Chinese herbal medicine granules placebo

Lihui Hou, MD

Xiaoke Wu, MD. PhD

Muer An, MD

Lihui Hou, MD.

Xiaoguang Shao, MD

Xin Sun, MD

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.

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

The Effects of Chinese Herbal Medicine and Letrozole on Live Birth in Infertile Women With Polycystic Ovary Syndrome:A Double-blind Randomized Controlled Trial

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

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

weight, vital signs, and hip and waist measurements.

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.

renal and liver function tests and complete blood count.

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

Heilongjiang University of Chinese Medicine

Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital

Spots Global Cancer Trial Database for chinese herbal medicine granules