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

Sponsor

Zhongshan Bo Ai Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01784380

Collaborator

(none)

1,159

Enrollment

Locations

Duration (Months)

579.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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.	Drug: Diane-35;metformin;Clomiphene citrate; Human menopausal gonadotropin

Study Design

Study Type:

Observational

Actual Enrollment :

1159 participants

Observational Model:

Case-Control

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 43 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Elecsys2010,French KONTRON EUB-5500 color Doppler ultrasonic diagnostic apparatus	ZHONGSHAN City	Guangdong	China	528400
2	Reproductive Center of Bo Ai Hospital, Zhongshan	Zhongshan	Guangdong	China	528403