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

Polycystic Ovary Syndrome Clinical Trial

Official title:

Letrozole and Berberine in Infertile PCOS Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01116167
• Other study ID #: you070316
• Status: Recruiting
• Phase: N/A
• First received: April 27, 2010
• Last updated: May 17, 2013
• Start date: October 2009
• Est. completion date: December 2013

Study information

• Verified date: May 2013
• Source: Heilongjiang University of Chinese Medicine
• Contact: Yan Li, MD.PhD.
• Email: liyantcm[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 660
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

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

Intervention

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.
• 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
• 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.

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 LongNa Hospital	Daqing	Heilongjiang
China	Daqing Longnan hospital	Daqing	Heilongjiang
China	Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
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	Obstetrics and Gynecology,Heilongjiang University of Chinese Medicine	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	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	2nd Affiliated Hospital of Henan University of Chinese Medicine	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Heilongjiang University of Chinese Medicine	Ministry of Science and Technology of the People´s Republic of China

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	Ongoing pregnancy rate at around gestation 8-10 weeks		Up to 1 year	No
Secondary	Multiple pregnancy rate		Up to 1 year.	No
Secondary	Miscarriage rate: loss of an intrauterine pregnancy before 20 completed weeks of gestation		Up to 1 year	No
Secondary	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	No
Secondary	Infant outcome		Up to 1 year	No
Secondary	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	No
Secondary	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	No
Secondary	Side effect.		Up to 1 year	No