Polycystic Ovary Syndrome (PCOS): Effect Of Letrozole and Berberine

• Sponsor: Heilongjiang University of Chinese Medicine (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01116167
• Collaborator: Ministry of Science and Technology of the People´s Republic of China (Other)
• Enrollment: 660
• Locations: 18
• Arms: 3
• Duration (Months): 50
• Patients Per Site: 36.7
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

Polycystic ovary syndrome (PCOS) is a heterogeneous disorder affecting almost4%-7% of the female population of reproductive age. Its heterogeneity is characterized by a wide spectrum of features, including ovulatory dysfunction and infertility, hyperandrogenism, hyperinsulinemia, insulin resistance (IR), and progression to type 2 diabetes.Since the Ming Dynasty in China,PCOS has been defined as "phlegm and wetness"infertility in traditional Chinese medicine ,namely "metabolic infertility".Chinese herbs have been used to treat PCOS for thousands of years with good effects.Berberine has also been used for diabetic patients in traditional Chinese medicine for hundreds of years. Recent studies have reported its effects on hyperglycemia and dyslipidemia.The purpose of this study is to determine whether Letrozole combined with berberine are effective in the treatment of infertile PCOS patients.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: Letrozole -Berberine; Drug: Letrozole; Drug: Berberine	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 660 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Letrozole and Berberine in Infertile PCOS Patients
• Study Start Date: Oct 1, 2009
• Anticipated Primary Completion Date: Dec 1, 2013
• Anticipated Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Letrozole -Berberine	Drug: Letrozole -Berberine; 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. Berberine 1.5g daily for 6 month.
Active Comparator: Letrozole	Drug: Letrozole; 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. Berberine Placebo 5 tablet tds for 6 months
Active Comparator: Berberine	Drug: Berberine; Berberine 1.5g daily for 6 month. Letrozole placebo 1 tablet daily from day 5 of the menses for 5 days for month 1 to 3, 2 tablets 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. Ongoing pregnancy rate at around gestation 8-10 weeks [Up to 1 year]

3. Multiple pregnancy rate [Up to 1 year.]

4. Miscarriage rate: loss of an intrauterine pregnancy before 20 completed weeks of gestation [Up to 1 year]

5. Other pregnancy complications such as early pregnancy loss, gestational diabetes mellitus, pregnancy-induced hypertension and birth of small-for-gestational-age (SGA) babies. [Up to 1 year]

6. Infant outcome [Up to 1 year]

7. Changes in metabolic profile: glucose and insulin concentrations, cholesterol, triglycerides, high density lipoprotein (HDL-C) and low density lipoprotein (LDL-C) [Up to 1 year]

8. Changes in hormonal profile: Follicle-stimulating hormone (FSH), Luteinizing hormone (LH), total testosterone (T), Sex hormone-binding globulin (SHBG) and Dehydroepiandrosterone sulfate (DHEAS) [Up to 1 year]

9. Side effect. [Up to 1 year]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Chinese women

• Age between 20 and 40 years.

• Confirmed diagnosis of PCOS according to the Rotterdam 2003 criteria (2 out of 3):

1. Oligo- or anovulation

2. Clinical and/or biochemical signs of hyperandrogenism

3. Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)

• At least one patent tube and normal uterine cavity shown by hysterosalpingogram, HyCoSi or diagnostic laparoscopy within three years.

• Sperm concentration 20×106/mL and progressive motility (grades a and b) ≥50%.

Exclusion Criteria:

• Use of hormonal drugs or other medications including Chinese herbal prescriptions in the past 3 months.

• Patients with known sever organ dysfunction or mental illness.

• Pregnancy, post-abortion or postpartum within the past 6 weeks.

• Breastfeeding within the last 6 months.

• Not willing to give written consent to the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Affiliated Hospital of Anhui University of Chinese Medicine	Hefei	Anhui	China
2	Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China
3	Guangzhou Medical School First Affiliated Hospital	Guangzhou	Guangdong	China
4	Daqing LongNa Hospital	Daqing	Heilongjiang	China	163000
5	Daqing Longnan hospital	Daqing	Heilongjiang	China
6	Obstetrics and Gynecology,Heilongjiang University of Chinese Medicine	Harbin	Heilongjiang	China	150040
7	First Affliated Hospital of Harbin Medical University	Harbin	Heilongjiang	China
8	Mudanjiang maternal and children hospital	Mudanjiang	Heilongjiang	China
9	2nd Affiliated Hospital of Henan University of Chinese Medicine	Zhengzhou	Henan	China
10	First Affiliated Hospital of Hunan University of Chinese	Changsha	Hunan	China
11	SuqianMaternal and Child Health Hospital	Suqian	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
• Ministry of Science and Technology of the People´s Republic of China

Investigators

• Study Chair: Lihui Hou, MD., The First Affliated Hospital,Heilongjiang University of Chinese Medicine .
• Study Chair: Xiaoke Wu, MD.PhD., The First Affliated Hospital,Heilongjiang University of Chinese Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiaoke Wu, Professor and Department Chairman of Obstetrics and Gynecology, Heilongjiang University of Chinese Medicine
• ClinicalTrials.gov Identifier: NCT01116167
• Other Study ID Numbers: you070316
• First Posted: May 4, 2010
• Last Update Posted: May 20, 2013
• Last Verified: May 1, 2013

• Keywords provided by Xiaoke Wu, Professor and Department Chairman of Obstetrics and Gynecology, Heilongjiang University of Chinese Medicine: Polycystic Ovary Syndrome
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Syndrome; Letrozole

Study Results

No Results Posted as of May 20, 2013