Clinical trial NCT01784380: 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
Study type: OBSERVATIONAL
Overall status: 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.
Lead sponsor: Zhongshan Bo Ai Hospital
Sponsor class: OTHER
First posted: 2013-02-05
Enrollment: 1159
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: after 5 weeks of ovulation treatment
Secondary outcomes:
Other outcomes:
Locations:
city: ZHONGSHAN City
country: China
facility: Elecsys2010,French KONTRON EUB-5500 color Doppler ultrasonic diagnostic apparatus
state: Guangdong
city: Zhongshan
country: China
facility: Reproductive Center of Bo Ai Hospital, Zhongshan
state: Guangdong
Study officials:
References:
citation: 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.