Estrogen (Gel)Transdermal vs Oral Estrogen for Endometrial Preparation

Sponsor
Indira IVF Hospital Pvt Ltd
Study ID
NCT05802303
Status
Terminated

Conditions

  • Frozen Embryo Transfer
  • Infertility, Female

Eligibility Criteria

Sex
FEMALE
Age
25 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • 17-beta Estradiol gel 0.06% w/w(ESTOGEL.Intas pharma) — DRUG
    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).
  • Estradiol Hemihydrate(Estrabet Tablet, abbott pharma) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 25, 2023
Status verified
Mar 2024
Primary completion
Mar 26, 2024
Completion
Mar 26, 2024

Study Design

Enrollment
172 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Transdermal Gel
    In the Estradiol gel group patients will be administered transdermal Estradiol gel (17-beta Estradiol gel 0.06%)
  • Other: Oral Estradiol
    In the Oral Estradiol group, all women will be given oral Estradiol valerate tablets

Primary Outcome Measure

Endometrial thickness (ET) [ Time Frame: 14 to 21 days after start of estrogen ]

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