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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01792362
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : May 6, 2015
Information provided by (Responsible Party):
Royan Institute

Brief 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

Condition or disease Intervention/treatment Phase
Infertility Other: Weight loss diet Phase 3

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: AMH
obese PCOS patients who underwent weight loss diet
Other: Weight loss diet
Control the patients diet to make them loosing weight

Primary Outcome Measures :
  1. Blood level of AMH [ Time Frame: 3 months ]
    Evaluation of Blood level of AMH 12 weeks after weight loss.

  2. Basal level of AMH [ Time Frame: 1 week ]
    Evaluation the Basal level of AMH before starting weight loss diet

Secondary Outcome Measures :
  1. Sensitivity of basal AMH level [ Time Frame: 6 months ]
    Evaluation the Sensitivity of basal AMH level for predict the response to weight loss diet

  2. specificity of basal AMH level [ Time Frame: 6 months ]
    Evaluation the specificity of basal AMH level for predict the response to weight loss diet

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01792362

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Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
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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

Additional Information:
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Responsible Party: Royan Institute Identifier: NCT01792362    
Other Study ID Numbers: Royan-Emb-015
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: November 2012
Keywords provided by Royan Institute:
Anti-mullerian hormone (AMH) level, poly cystic ovarian syndrome obese infertility weight loss diet
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Genital Diseases, Male
Genital Diseases, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs