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

• Sponsor: Heilongjiang University of Chinese Medicine (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01431352
• Collaborator: (none)
• Enrollment: 420
• Locations: 18
• Arms: 2
• Duration (Months): 59
• Patients Per Site: 23.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: Letrozole; Drug: Chinese herbal medicine granules or Chinese herbal medicine granules placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 420 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Sep 1, 2009
• Anticipated Primary Completion Date: Aug 1, 2014
• Anticipated Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Letrozole+ Chinese herbal medicine granules	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.; Drug: Chinese herbal medicine granules or Chinese herbal medicine granules placebo; twice a day for 6 month
Placebo Comparator: Letrozole+ Chinese herbal medicine granules placebo	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.

Outcome Measures

Primary Outcome Measures

1. Live birth rate [Up to 2 years]

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Affiliated Hospital of Anhui University of Chinese Medicine	Hefei	Anhui	China
2	Guangzhou Medical School First Affiliated Hospital	Guangzhou	Guangdong	China
3	Daqing Longnan hospital	Daqing	Heilongjiang	China
4	Daqing Oilfield General Hospital	Daqing	Heilongjiang	China
5	First Affliated Hospital of Harbin Medical University	Harbin	Heilongjiang	China	150001
6	Dept Obs & Gyn, First Affiliated Hospital National Key Discipline and Trial Base Heilongjiang University of Chinese Medicine	Herbin	Heilongjiang	China	150040
7	Mudanjiang maternal and children hospital	Mudanjiang	Heilongjiang	China
8	2nd Affiliated Hospital of Henan University of Chinese Medicine	Zhengzhou	Henan	China
9	First Affiliated Hospital of Hunan University of Chinese	Changsha	Hunan	China
10	SuqianMaternal and Child Health Hospital	Suqian	Jiangsu	China
11	Maternal and Child Health Hospital of Xuzhou	Xuzhou	Jiangsu	China
12	First Hospital, Jiangxi college of Chinese Medicine	Nanchang	Jiangxi	China
13	Dalian Maternal and Child Health Hospital	Dalian	Liaoning	China
14	Shanxi Hospital of Chinese Medicine	Taiyuan	Shanxi	China
15	First Affiliated Hospital of Tianjin University of Chinese Medicine	Tianjin	Tianjin	China
16	Second Affiliated Hospital, Tianjin University of Chinese Medicine	Tianjin	Tianjin	China
17	Zhejiang province hospital of integrated traditional and western medicine	Hangzhou	Zhejiang	China
18	Second Affiliated Hospital of Heilongjiang University of Chinese Medicine	Harbin		China

Sponsors and Collaborators

• Heilongjiang University of Chinese Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiaoke Wu, Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital, Heilongjiang University of Chinese Medicine
• ClinicalTrials.gov Identifier: NCT01431352
• Other Study ID Numbers: Letrozole
• First Posted: Sep 9, 2011
• Last Update Posted: Nov 5, 2013
• Last Verified: Nov 1, 2013

• Keywords provided by Xiaoke Wu, Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital, Heilongjiang University of Chinese Medicine: Polycystic ovary syndrome; Randomized controlled trial; Chinese herbal medicine; Chinese herbal medicine granules; Letrozole; Live birth
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Syndrome; Letrozole

Study Results

No Results Posted as of Nov 5, 2013