Effect of Combined Hormonal Contraceptiveson Free Androgen Index (FAI) in Polycystic Ovary Syndrome:Drospirenone-Ethinyl Estradiol (DRSP-EE) Versus Cyproterone Acetate-Ethinyl Estradiol (CPA-EE)

The quasi-experimental study was carried out from July 2023 to December 2024 in the Department of Reproductive Endocrinology \& Infertility, Bangladesh Medical University , Dhaka.Ethical clearance was obtained from the Institutional Review Board(approval no …).

A total of 60 subfertilewomen with PCOS, age 20-35 years was recruited for study.PCOS was diagnosed on the basis of Rotterdam criteria when at least two of the following were present: oligomenorrhoea (defined as delayed menses >35 days or <8 spontaneous menstrual cycle/ year), clinical hyperandrogenism (hirsutism, acne) orpolycystic ovarian morphology on ultrasonography >12 follicles in each ovary measuring 2-9 mm in diameter and/or increased ovarian volumes > 10cm3(Taylor et al., 2019). The exclusion criteria were contraindications of OCP (history of thromboembolic disorder, cerebrovascular disease, coronary artery disease, carcinoma of breast or other estrogen dependent neoplasm, undiagnosed abnormal genital bleeding, known or suspected pregnancy, abnormal liver and renal function, uncontrolled DM and HTN, dyslipidemia), recent use of androgen and anti-androgens within 3 months and other causes of anovulation/oligovulation.

The recruited participants were divided into two groups.DRSP-EE (Experimental) group received DRSP-EE(NOVELON, Renata Pharmaceuticals Limited) 1 tab daily (one active pill daily for 21 days and 7 inactive pills) for three cycles.CPA-EE (Comparator) groupreceivedCPA-EE (CLEO-35, Renata Pharmaceuticals Limited)1 tab daily (one active pill daily for 21 days and 7 pill free days) for three cycles.During the study period, patients were contacted every month over telephone and inquired about compliance to the regimen as well as any side effects.All participants were instructed not to take any other medications during the study except after consulting the investigator. Second visit was scheduled at the end of 3 months to assess the treatment outcome.

The primaryoutcomevariables were total testosterone, sex hormone binding globulin (SHBG) and free androgen index.Secondary outcome variables were fasting insulin, fasting glucose and HOMA-IR( Homeostatic Model Assessment of Insulin Resistance).Total testosteronewas determined by LIAISON Testosterone xl assay (Chemiluminescence immunoassay) by LIAISON XL Analyzer.SHBG was determined by DiaSorin LIAISON SHBG assay (Chemiluminescence immunoassay). Free Androgen Index (FAI) was calculated by the formulaFAI=Total testosterone (nmol/L)/ SHBG (nmol/L) × 100. Fasting insulin levels were determined by chemiluminescent microparticle immunoassay (CMIA). Fasting blood glucose estimation was done by enzymatic (Hexokinase/G-6-PDH) method.HOMA-IR was calculated by the formula HOMA-IR= Fasting glucose (mmol/L) ×Fasting insulin(mIU/ml) divided by 22.5. Blood samples were collected in the early morning, after an overnight fasting of 10 hours, for the measurement of fasting insulin and fasting glucose level.

Statistical analyses were carried out by using the Statistical Package for Social Sciences version 26.0 for Windows (SPSS Inc., Chicago, Illinois, USA). Data was tested using the t-test, chi-square test as appropriate. P values <0.05 was considered as statistically significant.