Evaluation of Anti-mullerian Hormone(AMH) Levels as a Predictive Factor of Response to Weight Los… (NCT01792362) | Clinical Trial Compass
CompletedPhase 3
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)
Iran60 participantsStarted 2012-10
Plain-language 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 infertile women with PCOS population
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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Inclusion Criteria:
\- 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 Criteria:
\- 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.