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

NCT01116167 | Unknown

• 1 other identifier: you070316
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 18

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.

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• Live-birth rate

  Up to 2 years

Secondary Outcomes (9)

• Ovulation rate

  Up to 1 year

• Ongoing pregnancy rate at around gestation 8-10 weeks

  Up to 1 year

• Multiple pregnancy rate

  Up to 1 year.

• Miscarriage rate: loss of an intrauterine pregnancy before 20 completed weeks of gestation

  Up to 1 year

• 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

Study Arms (3)

Letrozole -Berberine

EXPERIMENTAL

Drug: Letrozole -Berberine

Letrozole

ACTIVE COMPARATOR

Drug: Letrozole

Berberine

ACTIVE COMPARATOR

Drug: Berberine

Interventions

Letrozole -Berberine 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. Berberine 1.5g daily for 6 month.

Letrozole -Berberine

Letrozole 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. Berberine Placebo 5 tablet tds for 6 months

Letrozole

Berberine DRUG

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.

Berberine

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese women
• Age between 20 and 40 years.
• Confirmed diagnosis of PCOS according to the Rotterdam 2003 criteria (2 out of 3):
• Oligo- or anovulation
• Clinical and/or biochemical signs of hyperandrogenism
• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heilongjiang University of Chinese Medicine: lead
• Ministry of Science and Technology of the People´s Republic of China: collaborator

Study Sites (18)

Affiliated Hospital of Anhui University of Chinese Medicine

Hefei, Anhui, China

ACTIVE NOT RECRUITING

Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

ACTIVE NOT RECRUITING

Guangzhou Medical School First Affiliated Hospital

Guangzhou, Guangdong, China

RECRUITING

Daqing LongNa Hospital

Daqing, Heilongjiang, 163000, China

ACTIVE NOT RECRUITING

Daqing Longnan hospital

Daqing, Heilongjiang, China

ACTIVE NOT RECRUITING

Obstetrics and Gynecology,Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, 150040, China

RECRUITING

First Affliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

ACTIVE NOT RECRUITING

Mudanjiang maternal and children hospital

Mudanjiang, Heilongjiang, China

ACTIVE NOT RECRUITING

2nd Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, China

ACTIVE NOT RECRUITING

First Affiliated Hospital of Hunan University of Chinese

Changsha, Hunan, China

ACTIVE NOT RECRUITING

SuqianMaternal and Child Health Hospital

Suqian, Jiangsu, China

ACTIVE NOT RECRUITING

First Hospital, Jiangxi college of Chinese Medicine

Nanchang, Jiangxi, China

ACTIVE NOT RECRUITING

Dalian Maternal and Child Health Hospital

Dalian, Liaoning, China

ACTIVE NOT RECRUITING

Shanxi Hospital of Chinese Medicine

Taiyuan, Shanxi, China

ACTIVE NOT RECRUITING

First Affiliated Hospital of Tianjin University of Chinese Medicine

Tianjin, Tianjin Municipality, China

ACTIVE NOT RECRUITING

Second Affiliated Hospital, Tianjin University of Chinese Medicine

Tianjin, Tianjin Municipality, China

ACTIVE NOT RECRUITING

Zhejiang province hospital of integrated traditional and western medicine

Hangzhou, Zhejiang, China

ACTIVE NOT RECRUITING

Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

Harbin, China

ACTIVE NOT RECRUITING

Related Publications (2)

• Zhou K, Zhang J, Xu L, Lim CED. Chinese herbal medicine for subfertile women with polycystic ovarian syndrome. Cochrane Database Syst Rev. 2021 Jun 4;6(6):CD007535. doi: 10.1002/14651858.CD007535.pub4.

  PMID: 34085287 DERIVED

• Li Y, Kuang H, Shen W, Ma H, Zhang Y, Stener-Victorin E, Hung E, Ng Y, Liu J, Kuang H, Hou L, Wu X. Letrozole, berberine, or their combination for anovulatory infertility in women with polycystic ovary syndrome: study design of a double-blind randomised controlled trial. BMJ Open. 2013 Nov 25;3(11):e003934. doi: 10.1136/bmjopen-2013-003934.

  PMID: 24282248 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Letrozole; Berberine

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• 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 CHAIR

Central Study Contacts

Yan Li, MD.PhD.

CONTACT

liyantcm@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Department Chairman of Obstetrics and Gynecology

Study Record Dates

• First Submitted: April 27, 2010
• First Posted: May 4, 2010
• Study Start: October 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 20, 2013

Record last verified: 2013-05

Locations

CN (18)