Infertility Clinical Trial
Official title:
Comparing the Basal Anti-mullerian Hormone Levels Between Responders and Non-responders to Weight Loss Diet in Obese Infertile Women With PCOS Population
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
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 energy restriction. All subjects have the same dietary
protocol. At baseline, week 12 the levels of AMH,Follicular Stimulating Hormone (FSH),
Lutienizing Hormone(LH),Prolactin (PRL), androgens, sex hormone-binding globulin (SHBG),
glucose, and insulin were measured and Free Androgen Index (FAI) and Insulin Resistance (IR)
indices is calculated. The laboratory tests are determined by radioimmunoassay in the
Laboratory of Endocrinology of Royan institute. AMH is measured in duplicate using an
ultrasensitive ELISA kit (AMH-ELIZA Kit; Beckman Coulter, Marseilles, France) according to
manufacturer instructions. All measurements are performed using a single kit and at the same
time in the Laboratory of clinical Immunology of Royan institute.
Data collection will be performed by using questionnaire to be filled as per the available
records and laboratory results. Data analysis will be done through descriptive and
perceptive statistical methods.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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