Royan Institute
Tehran, Iran
NCT Number: NCT01792362
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
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Notify Me18 year–40 year
Female
Interventional
Phase 3
Tehran, Iran
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
2- Age between 18 -40
Exclusion criteria
Control the patients diet to make them loosing weight
Time frame: 3 months
Evaluation of Blood level of AMH 12 weeks after weight loss.
Time frame: 1 week
Evaluation the Basal level of AMH before starting weight loss diet
Time frame: 6 months
Evaluation the Sensitivity of basal AMH level for predict the response to weight loss diet
Time frame: 6 months
Evaluation the specificity of basal AMH level for predict the response to weight loss diet
Royan Institute
Other Gov
Comparing the Basal Anti-mullerian Hormone Levels Between Responders and Non-responders to Weight Loss Diet in Obese Infertile Women With PCOS Population
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