Status:
COMPLETED
Evaluation of Anti-mullerian Hormone(AMH) Levels as a Predictive Factor of Response to Weight Loss Treatment in Obese Infertile Women With Poly Cystic Ovary(PCOS)
Lead Sponsor:
Royan Institute
Conditions:
Infertility
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
Brief Summary
This study is a prospective before \& after clinical trial to compare the basal and 3 months after diet anti-mullerian hormone levels between responders and non-responders to weight loss diet in obese...
Detailed Description
The study population comprised of all obese infertile PCOS patients aged 20-40 years which underwent 3 months weight loss diet in royan institute, Tehran Iran. The study is conducted over 12 wk energ...
Eligibility Criteria
Inclusion
- \- 1- diagnosis of PCOS, according to the Rotterdam Consensus Workshop Group, by 2 of the following 3 criteria: menstrual irregularity (cycle length\<26 d or \>31 d or variation between consecutive cycles of \>3 d); clinical (hirsutism assessed by a Ferriman-Gallwey score \> 8) or biochemical \[free androgen index (FAI) \> 5.4 or testosterone\_1.4 nmol/L\] hyperandrogenism; or positive ultrasound presentation of polycystic ovaries by transvaginal scan.
- 2- Age between 18 -40
Exclusion
- \- 1. Body mass index (BMI; in kg/m2) \< 30, 2. Type 2 diabetes mellitus and related endocrinopathic disorders \[identified by assessment of thyroid-stimulating hormone (TSH), prolactin, and 17\_hydroxyprogesterone\].
- 3\. Regular exercise activities during the study. 4. Cases of alcoholism and smoking. 5. The use of endocrine hormonal treatment or insulin-sensitizing agents is not permitted during either phase of the study, and the use of oral contraceptives is not permitted during of the study. Subjects are required to cease taking oral contraceptives 4 wk and hormonal treatment or insulin-sensitizing agents 2 wk before commencement of the short-term study phase.
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01792362
Start Date
October 1 2012
End Date
April 1 2014
Last Update
May 6 2015
Active Locations (1)
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1
Royan Institute
Tehran, Iran