of Sodium Glucose Cotransporter-2 Inhibitors on Metabolic, Hormonal and Clinical Parameters in PCO

PCO Clinical Trial

Official title: Effect of Sodium Glucose Cotransporter-2 Inhibitors on Metabolic, Hormonal and Clinical Parameters in Infertile Women With Polycystic Ovary Syndrome

Status Recruiting

Clinical Trial Summary

The aim of this study is to compare the hormonal, metabolic and clinical effects of metformin and dapagliflozin as monotherapies and the effect of both of them as a combined therapy in infertile women with PCOs.

Clinical Trial Description

It is a Prospective randomized controlled trial .The study will include 200 randomly selected infertile women aged between 18 and 45 years, from Gynecology and obstetrics department Beni-Suef University Hospital whom diagnosed with polycystic ovarian syndrome (PCOS), according to Rotterdam criteria (BMI≥ 24kg/m, Homeostatic model assessment of insulin resistance (HOMA-IR with cutoff ≥ 2.5 biochemical hyperandrogenism, as indicated by a free androgen index (FAI) >4, and self-reported oligomenorrhea (cycle length >35 days and 9 or fewer periods per year) or amenorrhoea (absence of menses for a period ≥3 months) will be included for the study.

I The study will include four groups; each group consists of 50 patients:-

• Group I (n=50) will be treated by metformin monotherapy.

• Group II (n=50) will be treated by Dapagliflozin monotherapy .

• Group III (n=50) will be treated by metformin and dapagliflozin combined therapy

• Group IV (n=50) will be a control group. ;

Related Conditions & MeSH terms

• PCO

• NCT number: NCT05601336
• Study type: Interventional
• Source: Beni-Suef University
• Contact: Sara A Salem, MD
• Phone: 01272842226
• Email: sara_abdallah100@yahoo.com
• Status: Recruiting
• Phase: Phase 3
• Start date: January 15, 2022
• Completion date: July 30, 2023