Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405178
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-05-04
Brief Title:
Adjuvant Therapy With Letrozole in Induction of Ovulation With Polycystic Ovarian Syndrome
Sponsor:
Beni-Suef University
Organization:
Beni-Suef University
Study Overview
Official Title:
Sodium-Glucose Co-Transporter-2 Inhibitors as Adjuvant Therapy With Letrozole in Induction of Ovulation in Women With Polycystic Ovarian Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to assess the efficacy of adjuvant therapy dapagliflozin metformin as monotherapy and combination of both in comparison to control group in induction of ovulation with letrozole in women PCOS focusing specifically on rates of ovulation and pregnancy
Detailed Description:
The study will be a randomized controlled clinical trial Once the eligibility from screening visit is determined prior to baseline visit randomization will be made by computer randomization for women who are admitted to Beni-Suef University Hospital
Before initiation of the study the population will be divided randomly into 4 equal groups group A B C and D The adjuvant therapy of each group will be group A Metformin 1000mg group B Dapagliflozin 10mg GroupC Combined Dapagliflozin-Metformin 101000mg and group D with no adjuvant therapy control group
The adjuvant therapy will be taken once daily with a main meal and started one month before initiation of letrozole All groups will take letrozole 25mg twice daily from the third day of the cycle for 5 days
This treatment regimen will continue for three cycles unless positive pregnancy is achieved No diet restriction will be recommended during the study or change in the lifestyle The population will be asked to inform about any side effects that may happen during the study A written informed consent will be obtained from each woman participating in the study
Before initiation of the study the population will be divided randomly into 4 equal groups group A B C and D The adjuvant therapy of each group will be group A Metformin 1000mg group B Dapagliflozin 10mg GroupC Combined Dapagliflozin-Metformin 101000mg and group D with no adjuvant therapy control group
The adjuvant therapy will be taken once daily with a main meal and started one month before initiation of letrozole All groups will take letrozole 25mg twice daily from the third day of the cycle for 5 days
This treatment regimen will continue for three cycles unless positive pregnancy is achieved No diet restriction will be recommended during the study or change in the lifestyle The population will be asked to inform about any side effects that may happen during the study A written informed consent will be obtained from each woman participating in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None