Clinical trial NCT01792362: 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)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Keywords: Anti-mullerian hormone (AMH) level, poly cystic ovarian syndrome obese infertility weight loss diet
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2013-02-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Blood level of AMH
timeFrame: 3 months
measure: Basal level of AMH
timeFrame: 1 week
Secondary outcomes:
measure: Sensitivity of basal AMH level
timeFrame: 6 months
measure: specificity of basal AMH level
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Department of Endocrinology and Female Infertility, Reproductive Biomedicine Center, Royan institute for Reproductive Biomedicine, ACECR, Tehran, Iran
name: Ashraf Moini, MD
role: STUDY_DIRECTOR
References: