Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)

November 4, 2013 updated by: Xiaoke Wu, Heilongjiang University of Chinese Medicine

The Effects of Chinese Herbal Medicine and Letrozole on Live Birth in Infertile Women With Polycystic Ovary Syndrome:A Double-blind Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
420

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Harbin, China
        • Active, not recruiting
        • Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
    • Anhui
      • Hefei, Anhui, China
        • Active, not recruiting
        • Affiliated Hospital of Anhui University of Chinese Medicine
    • Guangdong
      • Guangzhou, Guangdong, China
        • Active, not recruiting
        • Guangzhou Medical School First Affiliated Hospital
    • Heilongjiang
      • Daqing, Heilongjiang, China
        • Active, not recruiting
        • Daqing Longnan Hospital
      • Daqing, Heilongjiang, China
        • Active, not recruiting
        • Daqing Oilfield General Hospital
      • Harbin, Heilongjiang, China, 150001
        • Recruiting
        • First Affliated Hospital of Harbin Medical University
        • Contact:
          • Muer An, MD
        • Principal Investigator:
          • Muer An, MD
      • Herbin, Heilongjiang, China, 150040
        • Recruiting
        • Dept Obs & Gyn, First Affiliated Hospital National Key Discipline and Trial Base Heilongjiang University of Chinese Medicine
        • Principal Investigator:
          • Lihui Hou, MD.
        • Contact:
          • Lihui Hou, MD.
          • Phone Number: 86-451-82130094
      • Mudanjiang, Heilongjiang, China
        • Active, not recruiting
        • Mudanjiang maternal and children hospital
    • Henan
      • Zhengzhou, Henan, China
        • Active, not recruiting
        • 2nd Affiliated Hospital of Henan University of Chinese Medicine
    • Hunan
      • Changsha, Hunan, China
        • Active, not recruiting
        • First Affiliated Hospital of Hunan University of Chinese
    • Jiangsu
      • Suqian, Jiangsu, China
        • Active, not recruiting
        • SuqianMaternal and Child Health Hospital
      • Xuzhou, Jiangsu, China
        • Active, not recruiting
        • Maternal and Child Health Hospital of Xuzhou
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Active, not recruiting
        • First Hospital, Jiangxi college of Chinese Medicine
    • Liaoning
      • Dalian, Liaoning, China
        • Recruiting
        • Dalian Maternal and Child Health Hospital
        • Principal Investigator:
          • Xiaoguang Shao, MD
    • Shanxi
      • Taiyuan, Shanxi, China
        • Active, not recruiting
        • Shanxi Hospital of Chinese Medicine
    • Tianjin
      • Tianjin, Tianjin, China
        • Active, not recruiting
        • First Affiliated Hospital of Tianjin University of Chinese Medicine
      • Tianjin, Tianjin, China
        • Active, not recruiting
        • Second Affiliated Hospital, Tianjin University of Chinese Medicine
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang province hospital of integrated traditional and western medicine
        • Contact:
          • Xin Sun, MD
        • Principal Investigator:
          • Xin Sun, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion criteria

  1. 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.
  2. History of at least one year of infertility.
  3. Age between 20 and 40 years old.
  4. 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.
  5. Normal uterine cavity and at least one tube patent upon hysterosalpingography or HyCoSy.

Exclusion criteria

  1. History of significant system diseases such as heart, lung, or kidney diseases.
  2. History of other endocrine disorders.
  3. Use of hormonal therapy, including metformin, in the past 3 months.
  4. Previous sterilization procedures (vasectomy or tubal ligation) that have been reversed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Letrozole+ Chinese herbal medicine granules
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.
Drug: Chinese herbal medicine granules or Chinese herbal medicine granules placebo
twice a day for 6 month
Placebo Comparator: Letrozole+ Chinese herbal medicine granules placebo
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Live birth rate
Time Frame: Up to 2 years
Up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ovulation rate
Time Frame: Up to 1 year
Up to 1 year
Miscarriage rate
Time Frame: Up to 1 year
Up to 1 year
Change in hormonal profile
Time Frame: Up to 1 year
Follicle-stimulating hormone, luteinizing hormone, total testosterone, sex hormone binding globulin, and dehydroepiandrosterone sulphate.
Up to 1 year
Change in metabolic profile
Time Frame: Up to 1 year
glucose and insulin concentrations, cholesterol, triglycerides, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol.
Up to 1 year
Change in physical measurements
Time Frame: Up to 1 year
weight, vital signs, and hip and waist measurements.
Up to 1 year
Pregnancy complications
Time Frame: Up to 1 year
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.
Up to 1 year
Birth defects
Time Frame: Up to 1 year
Up to 1 year
Safety parameters
Time Frame: Up to 1 year
renal and liver function tests and complete blood count.
Up to 1 year
Side effect profile
Time Frame: Up to 1 year
The major risks to the subject are side effects from letrozole and CHMG and the risks associated with pregnancy.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Heilongjiang University of Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • letrozole

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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