Estrogen (Gel)Transdermal vs Oral Estrogen for Endometrial Preparation

Not Applicable

Terminated

• Conditions: Frozen Embryo Transfer; Infertility, Female
• Interventions: Drug: 17-beta Estradiol gel 0.06% w/w(ESTOGEL.Intas pharma); Drug: Estradiol Hemihydrate(Estrabet Tablet, abbott pharma)

• Registration Number: NCT05802303
• Lead Sponsor: Indira IVF Hospital Pvt Ltd

Brief 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.

Detailed 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).

Study Timeline

• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-04-04
• Study First Posted: 2023-04-06
• Study Start: 2023-07-25
• Status Verified: 2024-03
• Primary Completion: 2024-03-26
• Study Completion: 2024-03-26
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 172

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transdermal Gel	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%)
Oral Estradiol	Estradiol Hemihydrate(Estrabet Tablet, abbott pharma)	In the Oral Estradiol group, all women will be given oral Estradiol valerate tablets

Primary Outcome Measures

Name	Time	Method
Endometrial thickness (ET)	14 to 21 days after start of estrogen	Average endometrial thickness achieved on day 14 of HRT

Secondary Outcome Measures

Name	Time	Method
Cycle cancelation rate	21 days after starting HRT	Number of cycles cancelled before embryo transfer × 100
Average E2 consumption	On 1 day of embryo transfer	Total E2 consumed till embryo transfer
Implantation rates (IR)	4 weeks + 2 weeks after embryo transfer	The number of gestational sacs observed by transvaginal ultrasound at the 6th gestational week per the number of embryos transferred.
Clinical pregnancy rates (CPR)	4 weeks + 2 weeks after embryo transfer	Detection of a foetal heartbeat on transvaginal ultrasound at the 6th gestational week per embryo transfer cycle
Miscarriage rates (MR)	Within 20 weeks of gestation	Number of spontaneous pregnancy losses in which a gestational sac was previously observed (before gestation week \<20 weeks) per 100 clinical pregnancy .
Patient satisfaction score	on 1 day of embryo transfer	It is measured using visual analogue scale(VAS) score

Trial Locations

Locations (1)

Indira IVF Hospital Private Limited; 🇮🇳 Udaipur, Rajasthan, India