Obesity in polycystic ovary syndrome women. Polycystic ovarian syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1-Diagnosis of PCOS, according to the Rotterdam Consensus Workshop Group, by 2 of the following 3 criteria: •Menstrual irregularity (cycle length31 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AMH serum level. Timepoint: Before and 12 weeks after starting the diet. Method of measurement: Laboratory (ELISA method). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Royan institute