Polycystic Ovarian Syndrome. Polycystic ovarian syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Aged between 20 to 38 years old Body mass index (BMI)=24 or anti-mullerian hormone (AMH) >=3.4)
Exclusion criteria
Exclusion criteria: Pregnancy or abortion during the last year before the start of the study History of other endocrinopathies such as adrenal hyperplasia, androgen-secreting tumors, hyperprolactinemia, thyroid dysfunction, diabetes, or impaired glucose tolerance Coexistence of other causes of infertility (severe male factor, tubal factor, uterine factor, endometriosis, Asherman syndrome, diminished ovarian reserves, etc.) Consumption of herbal or traditional medicine, antioxidant supplements, and vitamins within three months before the start of the study Taking ovulation-induction drugs, hormonal agents, and metformin within three months before the start of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of ovarian hyperstimulation syndrome (OHSS). Timepoint: From the day of the final ovarian trigger to 7 days after that. Method of measurement: The diagnosis of OHSS will be made by infertility specialist based on clinical, laboratory, and ultrasound findings.;Ovarian Response Indicators. Timepoint: At the day of the final ovarian trigger and oocyte retrieval day. Method of measurement: ultrasound.;Serum levels of estradiol and progesterone hormones. Timepoint: 6 weeks after the intervention beginning at the day of the final ovarian trigger. Method of measurement: ELISA test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Interleukin 6 (IL6) Level in Follicular Fluid (FF). Timepoint: 6 Weeks After the Intervention Beginning. Method of measurement: ELISA test.;Level of Vascular endothelial growth factor (VEGF) in FF. Timepoint: 6 Weeks After the Intervention Beginning. Method of measurement: ELISA test.;Expression Level of Receptor for AGE (RAGE) Gene in Ovarian Granulosa Cells (OGCs). Timepoint: 6 Weeks After the Intervention Beginning. Method of measurement: PCR test.;Inhibitor of Nuclear Factor kappa B - alpha (IkB-a) in OGCs. Timepoint: 6 Weeks After the Intervention Beginning. Method of measurement: Western Blot.;Phosphorylated Inhibitor of Nuclear Factor kappa B - alpha (pIkB-a) in OGCs. Timepoint: 6 Weeks After the Intervention Beginning. Method of measurement: Western Blot.;Severity of OHSS. Timepoint: Up to 7 days of the final trigger drug being given. Method of measurement: The diagnosis of OHSS will be made by infertility specialist based on clinical, laboratory, and ultrasound findings and will be divided to mild, moderate, sever, and critical types. | — |
Countries
Iran (Islamic Republic of)
Contacts
Tehran University of Medical Sciences