Infertility
Conditions
Keywords
Anti-mullerian hormone (AMH) level, poly cystic ovarian syndrome obese infertility weight loss diet
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.
Interventions
OTHERWeight loss diet
Control the patients diet to make them loosing weight
Sponsors
Royan Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood level of AMH | 3 months | Evaluation of Blood level of AMH 12 weeks after weight loss. |
| Basal level of AMH | 1 week | Evaluation the Basal level of AMH before starting weight loss diet |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of basal AMH level | 6 months | Evaluation the Sensitivity of basal AMH level for predict the response to weight loss diet |
| specificity of basal AMH level | 6 months | Evaluation the specificity of basal AMH level for predict the response to weight loss diet |
Countries
Iran
Outcome results
None listed