Back to resultsLetrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)
Primary Purpose
Polycystic Ovary Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Letrozole
Chinese herbal medicine granules or Chinese herbal medicine granules placebo
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic ovary syndrome, Randomized controlled trial, Chinese herbal medicine, Chinese herbal medicine granules, Letrozole, Live birth
Eligibility Criteria
Inclusion criteria
- Chinese women with PCOS. PCOS must have been diagnosed based on the presence of two of the following three Rotterdam criteria : (1) oligomenorrhea, anovulation; (2) hyperandrogenism; and (3) the observation of polycystic ovaries by sonography. Oligomenorrhea is defined as an intermenstrual interval >35 days or <8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days.
- History of at least one year of infertility.
- Age between 20 and 40 years old.
- Normal semen analysis based on World Health Organization criteria (2010). The husband did not need to sign the consent form because semen analysis is part of the clinical assessment at the sites. A sperm concentration ≥15 × 106/mL and total motility ≥40% in the semen analysis of the husband was required for the woman to be included.
- Normal uterine cavity and at least one tube patent upon hysterosalpingography or HyCoSy.
Exclusion criteria
- History of significant system diseases such as heart, lung, or kidney diseases.
- History of other endocrine disorders.
- Use of hormonal therapy, including metformin, in the past 3 months.
- Previous sterilization procedures (vasectomy or tubal ligation) that have been reversed.
Sites / Locations
- Affiliated Hospital of Anhui University of Chinese Medicine
- Guangzhou Medical School First Affiliated Hospital
- Daqing Longnan hospital
- Daqing Oilfield General Hospital
- First Affliated Hospital of Harbin Medical UniversityRecruiting
- Dept Obs & Gyn, First Affiliated Hospital National Key Discipline and Trial Base Heilongjiang University of Chinese MedicineRecruiting
- 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
- Maternal and Child Health Hospital of Xuzhou
- First Hospital, Jiangxi college of Chinese Medicine
- Dalian Maternal and Child Health HospitalRecruiting
- 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 medicineRecruiting
- Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Letrozole+ Chinese herbal medicine granules
Letrozole+ Chinese herbal medicine granules placebo
Arm Description
Outcomes
Primary Outcome Measures
Live birth rate
Secondary Outcome Measures
Ovulation rate
Miscarriage rate
Change in hormonal profile
Follicle-stimulating hormone, luteinizing hormone, total testosterone, sex hormone binding globulin, and dehydroepiandrosterone sulphate.
Change in metabolic profile
glucose and insulin concentrations, cholesterol, triglycerides, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol.
Change in physical measurements
weight, vital signs, and hip and waist measurements.
Pregnancy complications
gestational diabetes, pregnancy-induced hypertension, intrauterine growth retardation, ectopic pregnancy, congenital anomaly, preeclampsia, preterm labor, HELLP syndrome, preterm premature rupture of membranes, placental abruption, placenta accreta, placenta previa, postpartum hemorrhage, and others.
Birth defects
Safety parameters
renal and liver function tests and complete blood count.
Side effect profile
The major risks to the subject are side effects from letrozole and CHMG and the risks associated with pregnancy.
Full Information
NCT ID
NCT01431352
First Posted
September 6, 2011
Last Updated
November 4, 2013
Sponsor
Heilongjiang University of Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01431352
Brief Title
Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)
Official Title
The Effects of Chinese Herbal Medicine and Letrozole on Live Birth in Infertile Women With Polycystic Ovary Syndrome:A Double-blind Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heilongjiang University of Chinese Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a multicenter double-blind randomized controlled trial. A total of 420 anovulatory Chinese women with PCOS will be recruited, and the randomization will be stratified by each participating site. Participants will be randomized into one of the two treatment arms: letrozole and CHMG or letrozole and CHMG placebo. CHMG or its placebo will be taken twice a day for up to six months. Letrozole (2.5 mg daily) was given on days 3-7 of the menstrual cycle after a spontaneous period or withdrawal bleeding, and the dose will be increased to 5.0 mg daily during the last three months for non-pregnant women in both groups.The aim of the present study is to determine the efficacy of combined treatment with letrozole and CHMG on improving live birth rates in infertile Chinese women with PCOS. Our hypothesis is that the combination of letrozole and CHMG is more likely to increase the ovulation rate and decrease the miscarriage rate and result in a higher live birth rate in PCOS women than letrozole alone.
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, Randomized controlled trial, Chinese herbal medicine, Chinese herbal medicine granules, Letrozole, Live birth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Letrozole+ Chinese herbal medicine granules
Arm Type
Experimental
Arm Title
Letrozole+ Chinese herbal medicine granules placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Letrozole
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Chinese herbal medicine granules or Chinese herbal medicine granules placebo
Intervention Description
twice a day for 6 month
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
Miscarriage rate
Time Frame
Up to 1 year
Title
Change in hormonal profile
Description
Follicle-stimulating hormone, luteinizing hormone, total testosterone, sex hormone binding globulin, and dehydroepiandrosterone sulphate.
Time Frame
Up to 1 year
Title
Change in metabolic profile
Description
glucose and insulin concentrations, cholesterol, triglycerides, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol.
Time Frame
Up to 1 year
Title
Change in physical measurements
Description
weight, vital signs, and hip and waist measurements.
Time Frame
Up to 1 year
Title
Pregnancy complications
Description
gestational diabetes, pregnancy-induced hypertension, intrauterine growth retardation, ectopic pregnancy, congenital anomaly, preeclampsia, preterm labor, HELLP syndrome, preterm premature rupture of membranes, placental abruption, placenta accreta, placenta previa, postpartum hemorrhage, and others.
Time Frame
Up to 1 year
Title
Birth defects
Time Frame
Up to 1 year
Title
Safety parameters
Description
renal and liver function tests and complete blood count.
Time Frame
Up to 1 year
Title
Side effect profile
Description
The major risks to the subject are side effects from letrozole and CHMG and the risks associated with pregnancy.
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 with PCOS. PCOS must have been diagnosed based on the presence of two of the following three Rotterdam criteria : (1) oligomenorrhea, anovulation; (2) hyperandrogenism; and (3) the observation of polycystic ovaries by sonography. Oligomenorrhea is defined as an intermenstrual interval >35 days or <8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days.
History of at least one year of infertility.
Age between 20 and 40 years old.
Normal semen analysis based on World Health Organization criteria (2010). The husband did not need to sign the consent form because semen analysis is part of the clinical assessment at the sites. A sperm concentration ≥15 × 106/mL and total motility ≥40% in the semen analysis of the husband was required for the woman to be included.
Normal uterine cavity and at least one tube patent upon hysterosalpingography or HyCoSy.
Exclusion criteria
History of significant system diseases such as heart, lung, or kidney diseases.
History of other endocrine disorders.
Use of hormonal therapy, including metformin, in the past 3 months.
Previous sterilization procedures (vasectomy or tubal ligation) that have been reversed.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lihui Hou, MD
Phone
86-451-82130094
Email
houlihui2007@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoke Wu, MD. PhD
Phone
86-451-82130094
Email
xiaokewu2002@vip.sina.com
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
Guangzhou Medical School First Affiliated Hospital
City
Guangzhou
State/Province
Guangdong
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
Daqing Oilfield General Hospital
City
Daqing
State/Province
Heilongjiang
Country
China
Individual Site Status
Active, not recruiting
Facility Name
First Affliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muer An, MD
First Name & Middle Initial & Last Name & Degree
Muer An, MD
Facility Name
Dept Obs & Gyn, First Affiliated Hospital National Key Discipline and Trial Base Heilongjiang University of Chinese Medicine
City
Herbin
State/Province
Heilongjiang
ZIP/Postal Code
150040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lihui Hou, MD.
Phone
86-451-82130094
First Name & Middle Initial & Last Name & Degree
Lihui Hou, MD.
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
Maternal and Child Health Hospital of Xuzhou
City
Xuzhou
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoguang Shao, MD
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Sun, MD
First Name & Middle Initial & Last Name & Degree
Xin Sun, MD
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
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Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)
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