PCOSNIL in Polycystic Ovarian Syndrome

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2023
INTERVENTION: CONDITION: Health Condition 1: N970‐ Female infertility associated withanovulation PRIMARY OUTCOME: Change in Insulin resistance â?? HOMA ‐IR (Homeostasis model assessment of Insulin resistance)Timepoint: time points will be ; 1. Baseline. ; 2. on completion of 12 weeks. ; 3. On completion of 24 weeks. SECONDARY OUTCOME: Change in AMHTimepoint: At 12 week and 24 week Change in BMITimepoint: Every 4 Weeks Change in FINS.Timepoint: At 12 weeks and 24 Weeks Change in FPGTimepoint: At 12 Week and 24 Week Change in LHTimepoint: At 12 weeks and 24 Weeks Change in ProlactinTimepoint: At 12 week and 24 week Change in testosterone levelsTimepoint: At 12 Weeks and 24 Weeks Change in TNF â?? alphaTimepoint: At 12 Week and 24 Week Change in WHRTimepoint: Every 4 Weeks Change of FSH.Timepoint: At 12 Week and 24 Week OvulationTimepoint: Every 4 weeks Regulation of menstruationTimepoint: every 4 weeks INCLUSION CRITERIA: 1. Age â?? 18‐45years. 2. Gender â?? Female. 3. Diagnosis of PCOS with Rotterdam criteria. (Any 2 of the 3) a. Oligo/anovulation. b. Hyperandrogenism. i. Virilization. ii. Sr. testosterone > 70 ng/dl c. Polycystic ovaries on USG i. Follicles >12 (measuring 2‐9mm) ii. Ovarian volume > 10 ml. 4. BMI > 25Kg/m2. 5. Ready to give written informed consent.
Epistemonikos ID: c889a83dfb42a0cfb11fccd3474b475aac86176a
First added on: Feb 20, 2024