TerminatedNot Applicable

Estrogen (Gel)Transdermal vs Oral Estrogen for Endometrial Preparation

Stopped: As per institutional protocol unable to recruit adequate number of patients

India172 participantsStarted 2023-07-25

Plain-language 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.

Who can participate

Age range25 Years – 35 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Endometrial thickness (ET)

Timeframe: 14 to 21 days after start of estrogen

Trial details

NCT IDNCT05802303

SponsorIndira IVF Hospital Pvt Ltd

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-26