PCO
Conditions
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.
Interventions
SGLT2 inhibitor
DRUGMetformin Hydrochloride 1000 MG
metformin
SGLT2 inhibitor and metformin HCl extended-release
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
1. congenital adrenal hyperplasia 2. poorly controlled thyroid disease 3. Taking antidiabetic drugs which can affect insulin resistance 4. chronic kidney disease and history of recurrent urinary tract infections 5. liver dysfunction (AST or ALT \> 3 times the upper limit of normal or GFR\<30 ml/min/1.73m2) 6. documented use of oral hormonal contraceptives and hormone-releasing implants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ovulation | 3 cycles ( 3 months / one month for each cycle) | folliculometry by ultrasound |
| Cummulative rate of pregnancy | 3 months | HCG test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting blood sugar (FBS)/ 2 hpp | 3 months | — |
| Free Androgen Index (FAI) | 3 months | — |
| Total Testosterone (TT) | 3 months | — |
| Body weight changes | 3 months | weight loss by Kg |
| lipid profile | 3 months | — |
| ALT | 3 months | — |
| side effects | 3 months | Number of patients will report nausea / diarrhea/ lactic acidosis |
| FSH*LH*E2 | 3 months | — |
| changes of Menstrual cycle | 3 months | history from the patient |
Countries
Egypt
Contacts
Primary ContactSara A Salem, MD
Outcome results
None listed