Estrogen (Gel)Transdermal vs Oral Estrogen for Endometrial Preparation

Indira IVF Hospital Pvt Ltd

Status: Terminated

Conditions: Frozen Embryo Transfer; Infertility, Female

Treatments: Drug: 17-beta Estradiol gel 0.06% w/w(ESTOGEL.Intas pharma); Drug: Estradiol Hemihydrate(Estrabet Tablet, abbott pharma)

Study type: Interventional

Funder types: Other

Identifiers

NCT05802303

IIHPL-UDR/RCT/002_2022

Details and patient eligibility

About

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.

Full 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).

Enrollment: 172 patients

Sex: Female

Ages: 25 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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172 participants in 2 patient groups

Transdermal Gel

Active Comparator group

Description:

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

Treatment:

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

Oral Estradiol

Other group

Description:

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

Treatment:

Drug: Estradiol Hemihydrate(Estrabet Tablet, abbott pharma)