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

Primary Purpose

Polycystic Ovary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Letrozole -Berberine
Letrozole
Berberine
Sponsored by
Heilongjiang University of Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic Ovary Syndrome

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Affiliated Hospital of Anhui University of Chinese Medicine
  • Affiliated Hospital of Guangzhou Medical University
  • Guangzhou Medical School First Affiliated HospitalRecruiting
  • Daqing LongNa Hospital
  • Daqing Longnan hospital
  • Obstetrics and Gynecology,Heilongjiang University of Chinese MedicineRecruiting
  • First Affliated Hospital of Harbin Medical University
  • Mudanjiang maternal and children hospital
  • 2nd Affiliated Hospital of Henan University of Chinese Medicine
  • First Affiliated Hospital of Hunan University of Chinese
  • SuqianMaternal and Child Health Hospital
  • First Hospital, Jiangxi college of Chinese Medicine
  • Dalian Maternal and Child Health Hospital
  • Shanxi Hospital of Chinese Medicine
  • First Affiliated Hospital of Tianjin University of Chinese Medicine
  • Second Affiliated Hospital, Tianjin University of Chinese Medicine
  • Zhejiang province hospital of integrated traditional and western medicine
  • Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Letrozole -Berberine

Letrozole

Berberine

Arm Description

Outcomes

Primary Outcome Measures

Live-birth rate

Secondary Outcome Measures

Ovulation rate
Ongoing pregnancy rate at around gestation 8-10 weeks
Multiple pregnancy rate
Miscarriage rate: loss of an intrauterine pregnancy before 20 completed weeks of gestation
Other pregnancy complications such as early pregnancy loss, gestational diabetes mellitus, pregnancy-induced hypertension and birth of small-for-gestational-age (SGA) babies.
Infant outcome
Changes in metabolic profile: glucose and insulin concentrations, cholesterol, triglycerides, high density lipoprotein (HDL-C) and low density lipoprotein (LDL-C)
Changes in hormonal profile: Follicle-stimulating hormone (FSH), Luteinizing hormone (LH), total testosterone (T), Sex hormone-binding globulin (SHBG) and Dehydroepiandrosterone sulfate (DHEAS)
Side effect.

Full Information

First Posted
April 27, 2010
Last Updated
May 17, 2013
Sponsor
Heilongjiang University of Chinese Medicine
Collaborators
Ministry of Science and Technology of the People´s Republic of China
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1. Study Identification

Unique Protocol Identification Number
NCT01116167
Brief Title
Polycystic Ovary Syndrome (PCOS): Effect Of Letrozole and Berberine
Official Title
Letrozole and Berberine in Infertile PCOS Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heilongjiang University of Chinese Medicine
Collaborators
Ministry of Science and Technology of the People´s Republic of China

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Polycystic Ovary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
660 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Letrozole -Berberine
Arm Type
Experimental
Arm Title
Letrozole
Arm Type
Active Comparator
Arm Title
Berberine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Letrozole -Berberine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Letrozole
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Berberine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Live-birth rate
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Ovulation rate
Time Frame
Up to 1 year
Title
Ongoing pregnancy rate at around gestation 8-10 weeks
Time Frame
Up to 1 year
Title
Multiple pregnancy rate
Time Frame
Up to 1 year.
Title
Miscarriage rate: loss of an intrauterine pregnancy before 20 completed weeks of gestation
Time Frame
Up to 1 year
Title
Other pregnancy complications such as early pregnancy loss, gestational diabetes mellitus, pregnancy-induced hypertension and birth of small-for-gestational-age (SGA) babies.
Time Frame
Up to 1 year
Title
Infant outcome
Time Frame
Up to 1 year
Title
Changes in metabolic profile: glucose and insulin concentrations, cholesterol, triglycerides, high density lipoprotein (HDL-C) and low density lipoprotein (LDL-C)
Time Frame
Up to 1 year
Title
Changes in hormonal profile: Follicle-stimulating hormone (FSH), Luteinizing hormone (LH), total testosterone (T), Sex hormone-binding globulin (SHBG) and Dehydroepiandrosterone sulfate (DHEAS)
Time Frame
Up to 1 year
Title
Side effect.
Time Frame
Up to 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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): Oligo- or anovulation Clinical and/or biochemical signs of hyperandrogenism 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Li, MD.PhD.
Email
liyantcm@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lihui Hou, MD.
Organizational Affiliation
The First Affliated Hospital,Heilongjiang University of Chinese Medicine .
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xiaoke Wu, MD.PhD.
Organizational Affiliation
The First Affliated Hospital,Heilongjiang University of Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Affiliated Hospital of Anhui University of Chinese Medicine
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Guangzhou Medical School First Affiliated Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongxia Ma, MD
Facility Name
Daqing LongNa Hospital
City
Daqing
State/Province
Heilongjiang
ZIP/Postal Code
163000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Daqing Longnan hospital
City
Daqing
State/Province
Heilongjiang
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Obstetrics and Gynecology,Heilongjiang University of Chinese Medicine
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoke Wu, MD.PhD.
Phone
86-451-8213 0094
Email
xiaokewu2002@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Lihui Hou, MD.
Phone
86-451-8213 0094
Email
houlihui2007@sina.com
First Name & Middle Initial & Last Name & Degree
Lihui Hou, MD.
First Name & Middle Initial & Last Name & Degree
Xiaoke Wu, MD.PhD.
Facility Name
First Affliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Mudanjiang maternal and children hospital
City
Mudanjiang
State/Province
Heilongjiang
Country
China
Individual Site Status
Active, not recruiting
Facility Name
2nd Affiliated Hospital of Henan University of Chinese Medicine
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
First Affiliated Hospital of Hunan University of Chinese
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
SuqianMaternal and Child Health Hospital
City
Suqian
State/Province
Jiangsu
Country
China
Individual Site Status
Active, not recruiting
Facility Name
First Hospital, Jiangxi college of Chinese Medicine
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Dalian Maternal and Child Health Hospital
City
Dalian
State/Province
Liaoning
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Shanxi Hospital of Chinese Medicine
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Active, not recruiting
Facility Name
First Affiliated Hospital of Tianjin University of Chinese Medicine
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Second Affiliated Hospital, Tianjin University of Chinese Medicine
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Zhejiang province hospital of integrated traditional and western medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
City
Harbin
Country
China
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
34085287
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.
Results Reference
derived
PubMed Identifier
24282248
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.
Results Reference
derived

Learn more about this trial

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

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