Clinical trial NCT01116167: Polycystic Ovary Syndrome (PCOS): Effect Of Letrozole and Berberine
Official title: Letrozole and Berberine in Infertile PCOS Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome
Lead sponsor: Heilongjiang University of Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2010-05-04
Enrollment: 660
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Live-birth rate
timeFrame: Up to 2 years
Secondary outcomes:
measure: Ovulation rate
timeFrame: Up to 1 year
measure: Ongoing pregnancy rate at around gestation 8-10 weeks
timeFrame: Up to 1 year
measure: Multiple pregnancy rate
timeFrame: Up to 1 year.
measure: Miscarriage rate: loss of an intrauterine pregnancy before 20 completed weeks of gestation
timeFrame: Up to 1 year
measure: Other pregnancy complications such as early pregnancy loss, gestational diabetes mellitus, pregnancy-induced hypertension and birth of small-for-gestational-age (SGA) babies.
timeFrame: Up to 1 year
measure: Infant outcome
timeFrame: Up to 1 year
measure: Changes in metabolic profile: glucose and insulin concentrations, cholesterol, triglycerides, high density lipoprotein (HDL-C) and low density lipoprotein (LDL-C)
timeFrame: Up to 1 year
measure: Changes in hormonal profile: Follicle-stimulating hormone (FSH), Luteinizing hormone (LH), total testosterone (T), Sex hormone-binding globulin (SHBG) and Dehydroepiandrosterone sulfate (DHEAS)
timeFrame: Up to 1 year
measure: Side effect.
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Hefei
country: China
facility: Affiliated Hospital of Anhui University of Chinese Medicine
state: Anhui
city: Guangzhou
country: China
facility: Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Medical School First Affiliated Hospital
state: Guangdong
city: Daqing
country: China
facility: Daqing LongNa Hospital
state: Heilongjiang
city: Daqing
country: China
facility: Daqing Longnan hospital
state: Heilongjiang
city: Harbin
country: China
facility: Obstetrics and Gynecology,Heilongjiang University of Chinese Medicine
state: Heilongjiang
city: Harbin
country: China
facility: First Affliated Hospital of Harbin Medical University
state: Heilongjiang
city: Mudanjiang
country: China
facility: Mudanjiang maternal and children hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: 2nd Affiliated Hospital of Henan University of Chinese Medicine
state: Henan
city: Changsha
country: China
facility: First Affiliated Hospital of Hunan University of Chinese
state: Hunan
city: Suqian
country: China
facility: SuqianMaternal and Child Health Hospital
state: Jiangsu
city: Nanchang
country: China
facility: First Hospital, Jiangxi college of Chinese Medicine
state: Jiangxi
city: Dalian
country: China
facility: Dalian Maternal and Child Health Hospital
state: Liaoning
city: Taiyuan
country: China
facility: Shanxi Hospital of Chinese Medicine
state: Shanxi
city: Tianjin
country: China
facility: First Affiliated Hospital of Tianjin University of Chinese Medicine
state: Tianjin
city: Tianjin
country: China
facility: Second Affiliated Hospital, Tianjin University of Chinese Medicine
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang province hospital of integrated traditional and western medicine
state: Zhejiang
city: Harbin
country: China
facility: Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Study officials:
affiliation: The First Affliated Hospital,Heilongjiang University of Chinese Medicine .
name: Lihui Hou, MD.
role: STUDY_CHAIR
affiliation: The First Affliated Hospital,Heilongjiang University of Chinese Medicine
name: Xiaoke Wu, MD.PhD.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.