Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05802303
Status:
TERMINATED
Last Update Posted:
2024-03-28
First Post:
2023-02-21
Brief Title:
Estrogen GelTransdermal vs Oral Estrogen for Endometrial Preparation
Sponsor:
Indira IVF Hospital Pvt Ltd
Organization:
Indira IVF Hospital Pvt Ltd
Study Overview
Official Title:
Safety and Efficacy of Transdermal Estrogen Gel Versus Oral Estrogen for Endometrial Preparation in Down-regulated Frozen Embryo Transfer FET Cycles-An Open-label Multi Centric Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
As per institutional protocol unable to recruit adequate number of patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomized study trial is to comparing transdermal estradiol gel and oral estradiol for endometrial preparation in the Frozen Embryo Transfer Cycle The main questions it aims to answer is Can Transdermal estrogen gel can be equally efficacious as compared to oral estrogen in hormone replacement FET HRT- FET cycles The Transdermal gel would have the added benefit of a higher patient comfort with fewer side effects and a better safety profile Participants planned for Frozen embryo transfer will undergo H-P-O axis suppression on previous cycle D21 of menses with gonadotropin-releasing hormoneGnRH agonist depot preparation Inj Decapeptyl 375 mg IM The study will compare Transdermal E2 gel with Oral E2 tabs The patients will be randomized into an oral and gel group and all patients will participate only once in the study
Detailed Description:
Estrogen priming is essential for the induction of progesterone receptors and to build endometrial thickness both of which play an important role in regulating endometrial receptivity Different routes of Estrogen administration are oral tablets transdermal patchgel and vaginal tablets
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