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)
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|ClinicalTrials.gov Identifier: NCT01792362|
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : May 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Other: Weight loss diet||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||April 2014|
obese PCOS patients who underwent weight loss diet
Other: Weight loss diet
Control the patients diet to make them loosing weight
- Blood level of AMH [ Time Frame: 3 months ]Evaluation of Blood level of AMH 12 weeks after weight loss.
- Basal level of AMH [ Time Frame: 1 week ]Evaluation the Basal level of AMH before starting weight loss diet
- Sensitivity of basal AMH level [ Time Frame: 6 months ]Evaluation the Sensitivity of basal AMH level for predict the response to weight loss diet
- specificity of basal AMH level [ Time Frame: 6 months ]Evaluation the specificity of basal AMH level for predict the response to weight loss diet
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|