Estrogen (Gel)Transdermal vs Oral Estrogen for Endometrial Preparation

March 26, 2024 updated by: Dr Vipin Chandra, Indira IVF Hospital Pvt Ltd

Safety and Efficacy of Transdermal Estrogen (Gel) Versus Oral Estrogen for Endometrial Preparation in Down-regulated Frozen Embryo Transfer (FET) Cycles-An Open-label Multi Centric Randomized Controlled Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Rajasthan
      • Udaipur, Rajasthan, India, 313001
        • Indira IVF Hospital Private Limited
        • Principal Investigator:
          • Vipin Chandra, DGO
        • Sub-Investigator:
          • Jaydeep Kale, DNB
        • Sub-Investigator:
          • Madhu Patil, DNB,DGO
        • Sub-Investigator:
          • Pratibha Binwal, DGO
        • Sub-Investigator:
          • Anjali Gahlan, MS,DNB
        • Sub-Investigator:
          • Puja Rani, MS
        • Sub-Investigator:
          • A Jhansi Rani, DGO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transdermal Gel
In the Estradiol gel group patients will be administered transdermal Estradiol gel (17-beta Estradiol gel 0.06%)
Drug: 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% w/w) 2 puffs thrice a day (each application contains 1.25 mg with 0.75 mg of the drug).
Other: Oral Estradiol
In the Oral Estradiol group, all women will be given oral Estradiol valerate tablets
Drug: Estradiol Hemihydrate(Estrabet Tablet, abbott pharma)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endometrial thickness (ET)
Time Frame: 14 to 21 days after start of estrogen
Average endometrial thickness achieved on day 14 of HRT
14 to 21 days after start of estrogen

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cycle cancelation rate
Time Frame: 21 days after starting HRT
Number of cycles cancelled before embryo transfer × 100
21 days after starting HRT
Average E2 consumption
Time Frame: On 1 day of embryo transfer
Total E2 consumed till embryo transfer
On 1 day of embryo transfer
Implantation rates (IR)
Time Frame: 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.
4 weeks + 2 weeks after embryo transfer
Clinical pregnancy rates (CPR)
Time Frame: 4 weeks + 2 weeks after embryo transfer
Detection of a foetal heartbeat on transvaginal ultrasound at the 6th gestational week per embryo transfer cycle
4 weeks + 2 weeks after embryo transfer
Miscarriage rates (MR)
Time Frame: 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 .
Within 20 weeks of gestation
Patient satisfaction score
Time Frame: on 1 day of embryo transfer
It is measured using visual analogue scale(VAS) score
on 1 day of embryo transfer

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Undesirable side effects between both the groups
Time Frame: Till 12 weeks of pregnancy
Symptoms like rash, itching ,burning, thromboembolic event
Till 12 weeks of pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indira IVF Hospital Pvt Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2023

Primary Completion (Actual)

March 26, 2024

Study Completion (Actual)

March 26, 2024

Study Registration Dates

First Submitted

February 21, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIHPL-UDR/RCT/002_2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be shared with other researchers after publication of primary results

IPD Sharing Time Frame

After 6 months of publication of primary results

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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