Estrogen (Gel)Transdermal vs Oral Estrogen for Endometrial Preparation

Indira IVF Hospital Pvt Ltd172 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

172

Conditions

Frozen Embryo Transfer Infertility, Female

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.

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 35 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Endometrial thickness (ET)

Average endometrial thickness achieved on day 14 of HRT

Time frame: 14 to 21 days after start of estrogen

Secondary Outcomes

Cycle cancelation rate

Number of cycles cancelled before embryo transfer × 100

Time frame: 21 days after starting HRT

Average E2 consumption

Total E2 consumed till embryo transfer

Time frame: On 1 day of embryo transfer

Implantation rates (IR)

The number of gestational sacs observed by transvaginal ultrasound at the 6th gestational week per the number of embryos transferred.

Time frame: 4 weeks + 2 weeks after embryo transfer

Clinical pregnancy rates (CPR)

Detection of a foetal heartbeat on transvaginal ultrasound at the 6th gestational week per embryo transfer cycle

Time frame: 4 weeks + 2 weeks after embryo transfer

Miscarriage rates (MR)

Number of spontaneous pregnancy losses in which a gestational sac was previously observed (before gestation week \<20 weeks) per 100 clinical pregnancy .

Time frame: Within 20 weeks of gestation

Patient satisfaction score

It is measured using visual analogue scale(VAS) score

Time frame: on 1 day of embryo transfer