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 currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Royan Institute
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01792362
First received: February 13, 2013
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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 Intervention Phase
Infertility
Other: Weight loss diet
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMH
obese PCOS patients who underwent weight loss diet
Other: Weight loss diet
Control the patients diet to make them loosing weight

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01792362

Contacts
Contact: Nasser Aghdami, MD,PhD +9821235622000 ext 504 nasser.aghdami@royaninstitute.org
Contact: Leila Arab, MD +982123562000 ext 414 leila.arab@yahoo.com

Locations
Iran, Islamic Republic of
Royan Institute Recruiting
Tehran, Iran, Islamic Republic of
Contact: Nasser Aghdami, MD,PhD    +982123562000 ext 504    nasser.aghdami@royaninstitute.org   
Contact: Leila Arab, MD    +982123562000 ext 414    leila.arab@yahoo.com   
Principal Investigator: Mandana Hemmat, MD         
Sub-Investigator: Arezoo Arabipour, MSc         
Sub-Investigator: Reza Salmanyazdi, PhD         
Sub-Investigator: Ali Akhlaghi, MSc         
Sub-Investigator: Jila Ahmadi, BSc         
Sponsors and Collaborators
Royan Institute
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01792362     History of Changes
Other Study ID Numbers: Royan-Emb-015
Study First Received: February 13, 2013
Last Updated: February 13, 2013
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
Anti-mullerian hormone (AMH) level, poly cystic ovarian syndrome obese infertility weight loss diet

Additional relevant MeSH terms:
Infertility
Weight Loss
Genital Diseases, Male
Genital Diseases, Female
Body Weight Changes
Body Weight
Signs and Symptoms
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2014