NCT05802303

Estrogen (Gel)Transdermal vs Oral Estrogen for Endometrial Preparation

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Indira IVF Hospital Pvt Ltd · Academic / Other
• Sex: Female
• Age: 25 Years – 35 Years
• Healthy volunteers: Not accepted

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 question\[s\] 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 hormone(GnRH) agonist depot preparation (Inj. Decapeptyl 3.75 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 (patch/gel), and vaginal (tablets).

Conditions

• Frozen Embryo Transfer
• Infertility, Female

Interventions

Type	Name	Description
DRUG	17-beta Estradiol gel 0.06% w/w(ESTOGEL.Intas pharma)	In the Estradiol gel group patients will be administered transdermal Estradiol gel (17-beta Estradiol gel 0.06% w/w) 2 puffs thrice a day (each application contains 1.25 mg with 0.75 mg of the drug).
DRUG	Estradiol Hemihydrate(Estrabet Tablet, abbott pharma)	In the oral Estradiol group, all women will be given 2 mg of Estradiol valerate tablets, one tablets thrice a day within 30 days of injection triptorelin depot. Endometrial assessment will be performed on D10 of HRT. Please see the flow diagram (in the annexure) for details.

Timeline

• Start date: 2023-07-25
• Primary completion: 2024-03-26
• Completion: 2024-03-26
• First posted: 2023-04-06
• Last updated: 2024-03-28

Locations

1 site across 1 country: India