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

Completed

• Conditions: The Investigators Collected 534 PCOS Patients as the Case Group,and 580 Infertile Women With Normal Ovulatory Cycle of the Control Group; At the Same Time, the Investigators Continuedly Collect Cases to October 2012, and Totally Collected 579 Patients With PCOS Altogether; 534 Patients in the Cases Group and 580 Women in the Control Group Received no Measures, While 579 Patients Received Drugs; The Investigators Monitored Basic Indexes in Blood of All the Subjects in This Suvey,and Also Monitored Indexes of 579 Patients After Treatment.
• Interventions: Drug: Diane-35;metformin;Clomiphene citrate; Human menopausal gonadotropin

• Registration Number: NCT01784380
• Lead Sponsor: Zhongshan Bo Ai Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted: 2013-01-30
• Status Verified: 2013-02
• Study First Submitted QC: 2013-02-02
• Last Update Submitted: 2013-02-02
• Study First Posted: 2013-02-05
• Last Update Posted: 2013-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1159

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
the treatment group	Diane-35;metformin;Clomiphene citrate; Human menopausal gonadotropin	Patients of the treatment group recieved drugs,then we observed drugs' treatment effect.

Primary Outcome Measures

Name	Time	Method
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	after 5 weeks of ovulation treatment

Trial Locations

Locations (2)

Elecsys2010,French KONTRON EUB-5500 color Doppler ultrasonic diagnostic apparatus; 🇨🇳 ZHONGSHAN City, Guangdong, China

Reproductive Center of Bo Ai Hospital, Zhongshan; 🇨🇳 Zhongshan, Guangdong, China