Evaluation blood level of anti-m?llerian hormone measurement efficiency in prediction of the response to weight loss diet in obese women with polycystic ovarian syndrome with infertility problem.

Not Applicable

• Conditions: Obesity in polycystic ovary syndrome women.; Polycystic ovarian syndrome

• Registration Number: IRCT201302241141N14
• Lead Sponsor: Royan institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 80

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;
•Positive ultrasound presentation of polycystic ovaries by transvaginal scan (More than 12 follicles 9-2 mm and increased ovarian volume greater than 10 cm3) .
2-Age between 18 -40 years old.
Exclusion criteria:
1.Body mass index (BMI; in kg/m2) < 30.
2.Type 2 diabetes mellitus.
3. Related endocrine disorders [identified by assessment of thyroid-stimulating hormone (TSH), prolactin, and 17_hydroxyprogesterone].
4.The use of medications affecting the hypothalamus - pituitary - ovarian axis and insulin-sensitizing agents (metformin) is not permitted during the study phase and 12 wk before commencement of the study phase. Also, the use of oral contraceptives is not permitted during and 4 wk before commencement of the study phase.
5.Cases of alcoholism and smoking.
6.Regular exercise activities during the study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AMH serum level. Timepoint: Before and 12 weeks after starting the diet. Method of measurement: Laboratory (ELISA method).

Secondary Outcome Measures

Name	Time	Method
FSH serum level. Timepoint: Before and 12 weeks after starting the diet. Method of measurement: Laboratory kits.;LH serum level. Timepoint: Before and 12 weeks after starting the diet. Method of measurement: Laboratory kits.;PRL serum level. Timepoint: Before and 12 weeks after starting the diet. Method of measurement: Laboratory kits.;Androgens serum level. Timepoint: Before and 12 weeks after starting the diet. Method of measurement: Laboratory kits.;Sex hormone–binding globulin (SHBG) serum level. Timepoint: Before and 12 weeks after e starting the diet. Method of measurement: Laboratory kits.;Free Androgen Index serum level (FAI). Timepoint: Before and 12 weeks after starting the diet. Method of measurement: Laboratory kits.;Insulin Resistance (IR) indices. Timepoint: Before and 12 weeks after starting the diet. Method of measurement: Laboratory kits.;Fasting insulin. Timepoint: Before and 12 weeks after starting the diet. Method of measurement: Laboratory kits.