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

NCT ID: NCT01784380

Last Updated: 2013-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1159 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2012-10-31

Brief Summary

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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

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Conditions

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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.

Study Design

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Observational Model Type

CASE_CONTROL

Study Groups

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the case group

No interventions assigned to this group

the control group

No interventions assigned to this group

the treatment group

Patients of the treatment group recieved drugs,then we observed drugs' treatment effect.

Diane-35;metformin;Clomiphene citrate; Human menopausal gonadotropin

Intervention Type DRUG

Interventions

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Diane-35;metformin;Clomiphene citrate; Human menopausal gonadotropin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zhongshan Bo Ai Hospital

OTHER

Sponsor Role lead

Responsible Party

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LIN Xiu-feng

physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Elecsys2010,French KONTRON EUB-5500 color Doppler ultrasonic diagnostic apparatus

Zhongshan, Guangdong, China

Site Status

Reproductive Center of Bo Ai Hospital, Zhongshan

Zhongshan, Guangdong, China

Site Status

Countries

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China

References

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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. 2008 Sep;90(3):727-30. doi: 10.1016/j.fertnstert.2007.06.079. Epub 2007 Nov 14.

Reference Type RESULT
PMID: 18001723 (View on PubMed)

Other Identifiers

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2006A165

Identifier Type: -

Identifier Source: org_study_id

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