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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
SGLT2 inhibitor
metformin
SGLT2 inhibitor and metformin HCl extended-release
Beni-suef university
Banī Suwayf, Beni Suweif Governorate, Egypt
RECRUITINGovulation
folliculometry by ultrasound
Time frame: 3 cycles ( 3 months / one month for each cycle)
Cummulative rate of pregnancy
HCG test
Time frame: 3 months
Body weight changes
weight loss by Kg
Time frame: 3 months
changes of Menstrual cycle
history from the patient
Time frame: 3 months
Fasting blood sugar (FBS)/ 2 hpp
Time frame: 3 months
Free Androgen Index (FAI)
Time frame: 3 months
Total Testosterone (TT)
Time frame: 3 months
FSH*LH*E2
Time frame: 3 months
lipid profile
Time frame: 3 months
ALT
Time frame: 3 months
side effects
Number of patients will report nausea / diarrhea/ lactic acidosis
Time frame: 3 months
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