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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:-
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metformin monotherapy | Active Comparator | Glucophage 1000 once daily |
|
| Dapagliflozin monotherapy . | Active Comparator | Farxiga once per day |
|
| metformin and dapagliflozin combined therapy | Active Comparator | Xigduo once daily |
|
| control group. | No Intervention | placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 5 MG | Drug | SGLT2 inhibitor |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight changes | weight loss by Kg | 3 months |
| changes of Menstrual cycle | history from the patient | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara A Salem, MD | Contact | 01272842226 | 02 | sara_abdallah100@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Beni-Suef University | Clinical Pharmacy Faculty of Pharmacy Beni-Suef University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni-suef university | Recruiting | Banī Suwayf | Beni Suweif Governorate | 62521 | Egypt |
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within 36 months
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Metformin Hydrochloride 1000 MG | Drug | metformin |
|
|
| Dapagliflozin/Metformin | Drug | SGLT2 inhibitor and metformin HCl extended-release |
|
|
| 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 |