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

534 Patients in the Cases Group and 580 Women in the Control Group Received no Measures, While 579 Patients Received Drugs; Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01784380
• Other study ID #: 2006A165
• Status: Completed
• Phase: N/A
• First received: January 30, 2013
• Last updated: February 2, 2013
• Start date: October 2006
• Est. completion date: October 2012

Study information

• Verified date: February 2013
• Source: Zhongshan Bo Ai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChina: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1159
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 43 Years

Eligibility

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

Observational Model: Case Control

Related Conditions & MeSH terms

• 534 Patients in the Cases Group and 580 Women in the Control Group Received no Measures, While 579 Patients Received Drugs;
• At the Same Time, the Investigators Continuedly Collect Cases to October 2012, and Totally Collected 579 Patients With PCOS Altogether;
• Polycystic Ovary Syndrome
• The Investigators Collected 534 PCOS Patients as the Case Group,and 580 Infertile Women With Normal Ovulatory Cycle of the Control Group;
• The Investigators Monitored Basic Indexes in Blood of All the Subjects in This Suvey,and Also Monitored Indexes of 579 Patients After Treatment.

Intervention

Drug:
• Diane-35;metformin;Clomiphene citrate; Human menopausal gonadotropin

Locations

Country	Name	City	State
China	Reproductive Center of Bo Ai Hospital, Zhongshan	Zhongshan	Guangdong
China	Elecsys2010,French KONTRON EUB-5500 color Doppler ultrasonic diagnostic apparatus	ZHONGSHAN City	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Bo Ai Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Zolghadri J, Tavana Z, Kazerooni T, Soveid M, Taghieh M. Relationship between abnormal glucose tolerance test and history of previous recurrent miscarriages, and beneficial effect of metformin in these patients: a prospective clinical study. Fertil Steril — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes