Clinical trial NCT01431352: Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)
Official title: The Effects of Chinese Herbal Medicine and Letrozole on Live Birth in Infertile Women With Polycystic Ovary Syndrome:A Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic ovary syndrome
Randomized controlled trial
Chinese herbal medicine
Chinese herbal medicine granules
Letrozole
Live birth
Lead sponsor: Heilongjiang University of Chinese Medicine
Sponsor class: OTHER
First posted: 2011-09-09
Enrollment: 420
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Live birth rate
timeFrame: Up to 2 years
Secondary outcomes:
measure: Ovulation rate
timeFrame: Up to 1 year
measure: Miscarriage rate
timeFrame: Up to 1 year
measure: Change in hormonal profile
timeFrame: Up to 1 year
measure: Change in metabolic profile
timeFrame: Up to 1 year
measure: Change in physical measurements
timeFrame: Up to 1 year
measure: Pregnancy complications
timeFrame: Up to 1 year
measure: Birth defects
timeFrame: Up to 1 year
measure: Safety parameters
timeFrame: Up to 1 year
measure: Side effect profile
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Hefei
country: China
facility: Affiliated Hospital of Anhui University of Chinese Medicine
state: Anhui
city: Guangzhou
country: China
facility: Guangzhou Medical School First Affiliated Hospital
state: Guangdong
city: Daqing
country: China
facility: Daqing Longnan hospital
state: Heilongjiang
city: Daqing
country: China
facility: Daqing Oilfield General Hospital
state: Heilongjiang
city: Harbin
country: China
facility: First Affliated Hospital of Harbin Medical University
state: Heilongjiang
city: Herbin
country: China
facility: Dept Obs & Gyn, First Affiliated Hospital National Key Discipline and Trial Base Heilongjiang University of Chinese Medicine
state: Heilongjiang
city: Mudanjiang
country: China
facility: Mudanjiang maternal and children hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: 2nd Affiliated Hospital of Henan University of Chinese Medicine
state: Henan
city: Changsha
country: China
facility: First Affiliated Hospital of Hunan University of Chinese
state: Hunan
city: Suqian
country: China
facility: SuqianMaternal and Child Health Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: Maternal and Child Health Hospital of Xuzhou
state: Jiangsu
city: Nanchang
country: China
facility: First Hospital, Jiangxi college of Chinese Medicine
state: Jiangxi
city: Dalian
country: China
facility: Dalian Maternal and Child Health Hospital
state: Liaoning
city: Taiyuan
country: China
facility: Shanxi Hospital of Chinese Medicine
state: Shanxi
city: Tianjin
country: China
facility: First Affiliated Hospital of Tianjin University of Chinese Medicine
state: Tianjin
city: Tianjin
country: China
facility: Second Affiliated Hospital, Tianjin University of Chinese Medicine
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang province hospital of integrated traditional and western medicine
state: Zhejiang
city: Harbin
country: China
facility: Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Study officials:
References: