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 range

25 Years – 35 Years

Sex

FEMALE

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Frozen Embryo Transfer trials