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

Study Overview
=================
Brief 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.

Detailed 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.

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

Conditions
-----------------
PCO

Intervention / Treatment
-----------------
* Drug: Dapagliflozin 5 MG
* Drug: Metformin Hydrochloride 1000 MG
* Drug: Dapagliflozin/Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women are aged between 18 and 45 years no pregnancy plan within the next 6 months polycystic ovarian syndrome (PCOS), according to Rotterdam criteria Exclusion Criteria: congenital adrenal hyperplasia poorly controlled thyroid disease Taking antidiabetic drugs which can affect insulin resistance chronic kidney disease and history of recurrent urinary tract infections liver dysfunction (AST or ALT > 3 times the upper limit of normal or GFR<30 ml/min/1.73m2) documented use of oral hormonal contraceptives and hormone-releasing implants

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: metformin monotherapy<br>Glucophage 1000 once daily | Drug: Metformin Hydrochloride 1000 MG<br>* metformin<br>* Other names: Glucophage 1000mg;|
| Active Comparator: Dapagliflozin monotherapy .<br>Farxiga once per day | Drug: Dapagliflozin 5 MG<br>* SGLT2 inhibitor<br>* Other names: [Farxiga];|
| Active Comparator: metformin and dapagliflozin combined therapy<br>Xigduo once daily | Drug: Dapagliflozin/Metformin<br>* SGLT2 inhibitor and metformin HCl extended-release<br>* Other names: Xigduo;|
| No Intervention: control group.<br>placebo | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ovulation | folliculometry by ultrasound | 3 cycles ( 3 months / one month for each cycle) | 
| Cummulative rate of pregnancy | HCG test | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight changes | weight loss by Kg | 3 months | 
| changes of Menstrual cycle | history from the patient | 3 months | 
| Fasting blood sugar (FBS)/ 2 hpp |  | 3 months | 
| Free Androgen Index (FAI) |  | 3 months | 
| Total Testosterone (TT) |  | 3 months | 
| FSH*LH*E2 |  | 3 months | 
| lipid profile |  | 3 months | 
| ALT |  | 3 months | 
| side effects | Number of patients will report nausea / diarrhea/ lactic acidosis | 3 months |