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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01784380
Recruitment Status : Completed
First Posted : February 5, 2013
Last Update Posted : February 5, 2013
Information provided by (Responsible Party):
LIN Xiu-feng, 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.

Condition or disease Intervention/treatment
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

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Study Type : Observational
Actual Enrollment : 1159 participants
Observational Model: Case Control
Study Start Date : October 2006
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   20 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01784380

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

Publications of Results:
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Responsible Party: LIN Xiu-feng, physician, Zhongshan Bo Ai Hospital Identifier: NCT01784380     History of Changes
Other Study ID Numbers: 2006A165
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013
Additional relevant MeSH terms:
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Genital Diseases, Male
Genital Diseases, Female
Cyproterone acetate, ethinyl estradiol drug combination
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Androgen Antagonists