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

Polycystic Ovary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01431352
• Other study ID #: Letrozole
• Status: Recruiting
• Phase: N/A
• First received: September 6, 2011
• Last updated: November 4, 2013
• Start date: September 2009
• Est. completion date: August 2014

Study information

• Verified date: November 2013
• Source: Heilongjiang University of Chinese Medicine
• Contact: Lihui Hou, MD
• Phone: 86-451-82130094
• Email: houlihui2007[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Letrozole
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
twice a day for 6 month

Locations

Country	Name	City	State
China	First Affiliated Hospital of Hunan University of Chinese	Changsha	Hunan
China	Dalian Maternal and Child Health Hospital	Dalian	Liaoning
China	Daqing Longnan hospital	Daqing	Heilongjiang
China	Daqing Oilfield General Hospital	Daqing	Heilongjiang
China	Guangzhou Medical School First Affiliated Hospital	Guangzhou	Guangdong
China	Zhejiang province hospital of integrated traditional and western medicine	Hangzhou	Zhejiang
China	First Affliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Second Affiliated Hospital of Heilongjiang University of Chinese Medicine	Harbin
China	Affiliated Hospital of Anhui University of Chinese Medicine	Hefei	Anhui
China	Dept Obs & Gyn, First Affiliated Hospital National Key Discipline and Trial Base Heilongjiang University of Chinese Medicine	Herbin	Heilongjiang
China	Mudanjiang maternal and children hospital	Mudanjiang	Heilongjiang
China	First Hospital, Jiangxi college of Chinese Medicine	Nanchang	Jiangxi
China	SuqianMaternal and Child Health Hospital	Suqian	Jiangsu
China	Shanxi Hospital of Chinese Medicine	Taiyuan	Shanxi
China	First Affiliated Hospital of Tianjin University of Chinese Medicine	Tianjin	Tianjin
China	Second Affiliated Hospital, Tianjin University of Chinese Medicine	Tianjin	Tianjin
China	Maternal and Child Health Hospital of Xuzhou	Xuzhou	Jiangsu
China	2nd Affiliated Hospital of Henan University of Chinese Medicine	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Heilongjiang University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate		Up to 2 years	No
Secondary	Ovulation rate		Up to 1 year	No
Secondary	Miscarriage rate		Up to 1 year	No
Secondary	Change in hormonal profile	Follicle-stimulating hormone, luteinizing hormone, total testosterone, sex hormone binding globulin, and dehydroepiandrosterone sulphate.	Up to 1 year	No
Secondary	Change in metabolic profile	glucose and insulin concentrations, cholesterol, triglycerides, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol.	Up to 1 year	No
Secondary	Change in physical measurements	weight, vital signs, and hip and waist measurements.	Up to 1 year	No
Secondary	Pregnancy complications	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.	Up to 1 year	No
Secondary	Birth defects		Up to 1 year	No
Secondary	Safety parameters	renal and liver function tests and complete blood count.	Up to 1 year	No
Secondary	Side effect profile	The major risks to the subject are side effects from letrozole and CHMG and the risks associated with pregnancy.	Up to 1 year	No