The Potential Biochemical Diagnosis Criteria and Therapeutic Effect Indexes: Sex Hormone Binding Globulin Levels and Free Androgen Index in Blood of Patients With Polycystic Ovary Syndrome

February 2, 2013 updated by: LIN Xiu-feng, Zhongshan Bo Ai Hospital
To explore whether Free androgen index（FAI）can be regarded as biochemically diagnostic indexes of high androgen hormone in blood of patients with Polycentric ovary syndrome（PCOS）. Also to explore whether Sex hormone-binding globulin（SHBG） and FAI can be seen as therapeutic effect indicatrixes of women with PCOS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1159

Contacts and Locations

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

Study Locations

  • China
    • Guangdong
      • ZHONGSHAN City, Guangdong, China, 528400
        • Elecsys2010,French KONTRON EUB-5500 color Doppler ultrasonic diagnostic apparatus
      • Zhongshan, Guangdong, China, 528403
        • Reproductive Center of Bo Ai Hospital, Zhongshan

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

Ages Eligible for Study

20 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The investigators collected 534 PCOS patients as the case group, 580 infertile women with normally ovulatory cycle as the control groupand.The patients of the case group aged from 20 to 42 years old, the average age was 27.87 years old, and the standard deviation of ages was 3.75 years old. And patients' ovulation in the case group was normal, as control group, aged from 20 to 43 years old, the average age was 28.18 years old; the standard deviation of ages was 3.99 years old.Also the investigators also collected 579 patients as the treatment group,who aged from 20 to 39 years, the average age was 27.93 years old, the standard deviation of ages was 3.70 years old.

Description

Inclusion Criteria:

  • The clinical diagnosis criteria for PCOS by European Society of Human Reproduction and Embryology, and Rotterdam working group of American Society for Reproductive Medicine (ESHRE /ASRM )

Exclusion Criteria:

  • hyperprolactinemia and other endocrine diseases such as high androgen hormone in blood, namely Cushing's syndrome, congenital adrenal hyperplasia ( CAH ), ovarian or adrenal tumor and so on

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
the case group
the control group
the treatment group
Patients of the treatment group recieved drugs,then we observed drugs' treatment effect.
Drug: Diane-35;metformin;Clomiphene citrate; Human menopausal gonadotropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The potentially biochemical diagnosis criteria and therapeutic effect evaluation indexes: Sex hormone binding globulin levels and free androgen index in blood of patients with polycystic ovary syndrome
Time Frame: after 5 weeks of ovulation treatment
after 5 weeks of ovulation treatment

Collaborators and Investigators

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

Sponsor

Zhongshan Bo Ai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2006

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

January 30, 2013

First Submitted That Met QC Criteria

February 2, 2013

First Posted (Estimate)

February 5, 2013

Study Record Updates

Last Update Posted (Estimate)

February 5, 2013

Last Update Submitted That Met QC Criteria

February 2, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006A165

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.

Clinical Trials on Diane-35;metformin;Clomiphene citrate; Human menopausal gonadotropin

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