Estrogen (Gel)Transdermal vs Oral Estrogen for Endometrial Preparation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-25

Study Completion Date

2024-03-26

Brief Summary

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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.

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Detailed Description

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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

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Frozen Embryo Transfer Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

All cases undergoing frozen embryo transfer with own or donor gametes.

Study Groups

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Transdermal Gel

In the Estradiol gel group patients will be administered transdermal Estradiol gel (17-beta Estradiol gel 0.06%)

Group Type ACTIVE_COMPARATOR

17-beta Estradiol gel 0.06% w/w(ESTOGEL.Intas pharma)

Intervention Type 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).

Oral Estradiol

In the Oral Estradiol group, all women will be given oral Estradiol valerate tablets

Group Type OTHER

Estradiol Hemihydrate(Estrabet Tablet, abbott pharma)

Intervention Type 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.

Interventions

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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).

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Infertile patients aged 23-35 years.
* BMI 18.5 to 29.9 kg/m2.
* A normal uterine cavity assessed by 3D ultrasound (USG)/hysteroscopy.
* Patients who underwent IVF/ICSI and who have cryopreserved their embryos.
* Those receiving donor oocytes or donor embryos.
* Patients undergoing hormonal replacement frozen embryo transfer (HRT-FET) cycles with GnRH agonist suppression.
* Embryo Transfers of good quality embryos -2/3/4/5 AA, AB, BA(As per Gardner Grading System).

Exclusion Criteria

* Preimplantation Genetic Testing for Aneuploidies (PGT-A) cycles.
* Patients who had a FET performed in natural or stimulated cycles.
* Patients who had more than 2 failed transfers due to thin endometrium.
* Patients having uterine anomalies.
* Known cases of adenomyosis and endometriosis.
* Underlying cardiac/renal/hepatic/thromboembolic disorders, h/o anxiety or depression.
* E2 \>50 pg./ml, P4 \> 1 ng/ml and on D2 of menses.
* On D2 scan presence of a cyst or a dominant follicle.
* Patients with a history of recurrent 1st-trimester abortions.

Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No