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)

NCT01792362 | Completed Phase 3

• 1 other identifier: Royan-Emb-015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Infertility

Keywords

Anti-mullerian hormone (AMH) level, poly cystic ovarian syndrome obese infertility weight loss diet

Outcome Measures

Primary Outcomes (2)

• Blood level of AMH

  Evaluation of Blood level of AMH 12 weeks after weight loss.

  3 months

• Basal level of AMH

  Evaluation the Basal level of AMH before starting weight loss diet

  1 week

Secondary Outcomes (2)

• Sensitivity of basal AMH level

  6 months

• specificity of basal AMH level

  6 months

Study Arms (1)

AMH

EXPERIMENTAL

obese PCOS patients who underwent weight loss diet

Other: Weight loss diet

Interventions

Weight loss diet OTHER

Control the patients diet to make them loosing weight

AMH

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.
• Age between 18 -40

You may not qualify if:

• \- 1. Body mass index (BMI; in kg/m2) \< 30, 2. Type 2 diabetes mellitus and related endocrinopathic disorders \[identified by assessment of thyroid-stimulating hormone (TSH), prolactin, and 17\_hydroxyprogesterone\].
• \. 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.

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Links

• Related Info

MeSH Terms

Conditions

Infertility

Interventions

Diet, Reducing

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Hamid Gourabi, PhD

  Head of Royan Institute

  STUDY CHAIR

• Ashraf Moini, MD

  Department of Endocrinology and Female Infertility, Reproductive Biomedicine Center, Royan institute for Reproductive Biomedicine, ACECR, Tehran, Iran

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2013
• First Posted: February 15, 2013
• Study Start: October 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: April 1, 2014
• Last Updated: May 6, 2015

Record last verified: 2012-11

Locations

IR (1)