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)
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
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Blood level of AMH [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Evaluation of Blood level of AMH 12 weeks after weight loss.
- Basal level of AMH [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]Evaluation the Basal level of AMH before starting weight loss diet
- Sensitivity of basal AMH level [ Time Frame: 6 months ] [ Designated as safety issue: No ]Evaluation the Sensitivity of basal AMH level for predict the response to weight loss diet
- specificity of basal AMH level [ Time Frame: 6 months ] [ Designated as safety issue: No ]Evaluation the specificity of basal AMH level for predict the response to weight loss diet
|Study Start Date:||October 2012|
|Study Completion Date:||April 2014|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
obese PCOS patients who underwent weight loss diet
Other: Weight loss diet
Control the patients diet to make them loosing weight
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01792362
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|Study Chair:||Hamid Gourabi, PhD||Head of Royan Institute|
|Study Director:||Ashraf Moini, MD||Department of Endocrinology and Female Infertility, Reproductive Biomedicine Center, Royan institute for Reproductive Biomedicine, ACECR, Tehran, Iran|