Frozen Embryo TransferNCT05802303
Estrogen (Gel)Transdermal vs Oral Estrogen for Endometrial Preparation
A study testing 17-beta Estradiol gel 0.06% w/w(ESTOGEL.Intas pharma) and Estradiol Hemihydrate(Estrabet Tablet, abbott pharma) in people with Frozen Embryo Transfer and Infertility, Female, run by Indira IVF Hospital Pvt Ltd at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Frozen Embryo Transfer, Infertility, Female
- What is being tested?
- 17-beta Estradiol gel 0.06% w/w(ESTOGEL.Intas pharma) and Estradiol Hemihydrate(Estrabet Tablet, abbott pharma)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteIndia
- Study dates
- 25 Jul 2023to 26 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Frozen Embryo Transfer, Infertility, Female
- Being tested
- 17-beta Estradiol gel 0.06% w/w(ESTOGEL.Intas pharma), Estradiol Hemihydrate(Estrabet Tablet, abbott pharma)
- Keywords
- Transdermal Estrogen, FET, Oral Estrogen, IVF/ICSI
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17-beta Estradiol gel 0.06% w/w(ESTOGEL.Intas pharma)Drug
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).
Estradiol Hemihydrate(Estrabet Tablet, abbott pharma)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Transdermal Gel | Active comparator | In the Estradiol gel group patients will be administered transdermal Estradiol gel (17-beta Estradiol gel 0.06%) Receives: Drug: 17-beta Estradiol gel 0.06% w/w(ESTOGEL.Intas pharma) |
| Oral Estradiol | Other | In the Oral Estradiol group, all women will be given oral Estradiol valerate tablets Receives: Drug: Estradiol Hemihydrate(Estrabet Tablet, abbott pharma) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial thickness (ET)
Average endometrial thickness achieved on day 14 of HRT
Measured: 14 to 21 days after start of estrogen
Secondary outcomes (6)
Cycle cancelation rate
Number of cycles cancelled before embryo transfer × 100
Measured: 21 days after starting HRT
Average E2 consumption
Total E2 consumed till embryo transfer
Measured: On 1 day of embryo transfer
Implantation rates (IR)
The number of gestational sacs observed by transvaginal ultrasound at the 6th gestational week per the number of embryos transferred.
Measured: 4 weeks + 2 weeks after embryo transfer
Clinical pregnancy rates (CPR)
Detection of a foetal heartbeat on transvaginal ultrasound at the 6th gestational week per embryo transfer cycle
Measured: 4 weeks + 2 weeks after embryo transfer
Miscarriage rates (MR)
Number of spontaneous pregnancy losses in which a gestational sac was previously observed (before gestation week <20 weeks) per 100 clinical pregnancy .
Measured: Within 20 weeks of gestation
Patient satisfaction score
It is measured using visual analogue scale(VAS) score
Measured: on 1 day of embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start25 Jul 2023
- Primary completion26 Mar 2024
- Study completion26 Mar 2024
Why it stopped: As per institutional protocol unable to recruit adequate number of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Frozen Embryo TransferStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indira IVF Hospital Pvt Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Vipin Chandra, Indira IVF Hospital Pvt Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802303
- Sponsor's protocol ID
- IIHPL-UDR/RCT/002_2022
- Status last verified
- Mar 2024
- First submitted
- 21 Feb 2023
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared with other researchers after publication of primary results
Publications
Bourdon M, Santulli P, Kefelian F, Vienet-Legue L, Maignien C, Pocate-Cheriet K, de Mouzon J, Marcellin L, Chapron C. Prolonged estrogen (E2) treatment prior to frozen-blastocyst transfer decreases the live birth rate. Hum Reprod. 2018 May 1;33(5):905-913. doi: 10.1093/humrep/dey041.
PubMed 29529202Scheffer JB, Scheffer BB, Aguiar APS, Franca JB, Lozano DM, Fanchin R. A comparison of the effects of three different estrogen used for endometrium preparation on the outcome of day 5 frozen embryo transfer cycle. JBRA Assist Reprod. 2021 Feb 2;25(1):104-108. doi: 10.5935/1518-0557.20200059.
PubMed 32991118Corroenne R, El Hachem H, Verhaeghe C, Legendre G, Dreux C, Jeanneteau P, Descamps P, May-Panloup P, Bouet PE. Endometrial preparation for frozen-thawed embryo transfer in an artificial cycle: transdermal versus vaginal estrogen. Sci Rep. 2020 Jan 22;10(1):985. doi: 10.1038/s41598-020-57730-3.
PubMed 31969591Devroey P, Pados G. Preparation of endometrium for egg donation. Hum Reprod Update. 1998 Nov-Dec;4(6):856-61. doi: 10.1093/humupd/4.6.856.
PubMed 10098476Garimella S, Karunakaran S, Gedela DR. A prospective study of oral estrogen versus transdermal estrogen (gel) for hormone replacement frozen embryo transfer cycles. Gynecol Endocrinol. 2021 Jun;37(6):515-518. doi: 10.1080/09513590.2020.1793941. Epub 2020 Jul 15.
PubMed 32666854Ranisavljevic N, Raad J, Anahory T, Grynberg M, Sonigo C. Embryo transfer strategy and therapeutic options in infertile patients with thin endometrium: a systematic review. J Assist Reprod Genet. 2019 Nov;36(11):2217-2231. doi: 10.1007/s10815-019-01576-w. Epub 2019 Sep 9.
PubMed 31502111Paulson RJ. Hormonal induction of endometrial receptivity. Fertil Steril. 2011 Sep;96(3):530-5. doi: 10.1016/j.fertnstert.2011.07.1097.
PubMed 21880274Shahrokh Tehraninejad E, Kabodmehri R, Hosein Rashidi B, Jafarabadi M, Keikha F, Masomi M, Hagholahi F. Trans dermal estrogen (oestrogel) for endometrial preparation in freeze embryo transfer cycle: An RCT. Int J Reprod Biomed. 2018 Jan;16(1):51-56.
PubMed 29675488
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05802303
- Acronym / sponsor ID
- IIHPL-UDR/RCT/002_2022
- Conditions
- Frozen Embryo Transfer, Infertility, Female
- Keywords
- Transdermal Estrogen, FET, Oral Estrogen, IVF/ICSI
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: As per institutional protocol unable to recruit adequate number of patients
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Indira IVF Hospital Pvt LtdUniversity, hospital or other
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 26 Mar 2024 (actual)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transdermal Gel | Active comparator | 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%) |
| Oral Estradiol | Other | Drug: Estradiol Hemihydrate(Estrabet Tablet, abbott pharma)In the Oral Estradiol group, all women will be given oral Estradiol valerate tablets |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Drug | Transdermal Gel |
| 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. | Drug | Oral Estradiol |
Primary outcome
Endometrial thickness (ET)
Time frame: 14 to 21 days after start of estrogen
Average endometrial thickness achieved on day 14 of HRT
6 secondary outcomes
Cycle cancelation rate
Time frame: 21 days after starting HRT
Average E2 consumption
Time frame: On 1 day of embryo transfer
Implantation rates (IR)
Time frame: 4 weeks + 2 weeks after embryo transfer
Clinical pregnancy rates (CPR)
Time frame: 4 weeks + 2 weeks after embryo transfer
Miscarriage rates (MR)
Time frame: Within 20 weeks of gestation
Patient satisfaction score
Time frame: on 1 day of embryo transfer
Results and safety
The study was stopped early (reason given: As per institutional protocol unable to recruit adequate number of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Background: PubMed 29529202Bourdon M, Santulli P, Kefelian F, Vienet-Legue L, Maignien C, Pocate-Cheriet K, de Mouzon J, Marcellin L, Chapron C. Prolonged estrogen (E2) treatment prior to frozen-blastocyst transfer decreases the live birth rate. Hum Reprod. 2018 May 1;33(5):905-913. doi: 10.1093/humrep/dey041.
- Background: PubMed 32991118Scheffer JB, Scheffer BB, Aguiar APS, Franca JB, Lozano DM, Fanchin R. A comparison of the effects of three different estrogen used for endometrium preparation on the outcome of day 5 frozen embryo transfer cycle. JBRA Assist Reprod. 2021 Feb 2;25(1):104-108. doi: 10.5935/1518-0557.20200059.
- Background: PubMed 31969591Corroenne R, El Hachem H, Verhaeghe C, Legendre G, Dreux C, Jeanneteau P, Descamps P, May-Panloup P, Bouet PE. Endometrial preparation for frozen-thawed embryo transfer in an artificial cycle: transdermal versus vaginal estrogen. Sci Rep. 2020 Jan 22;10(1):985. doi: 10.1038/s41598-020-57730-3.
- Background: PubMed 10098476Devroey P, Pados G. Preparation of endometrium for egg donation. Hum Reprod Update. 1998 Nov-Dec;4(6):856-61. doi: 10.1093/humupd/4.6.856.
- Background: PubMed 32666854Garimella S, Karunakaran S, Gedela DR. A prospective study of oral estrogen versus transdermal estrogen (gel) for hormone replacement frozen embryo transfer cycles. Gynecol Endocrinol. 2021 Jun;37(6):515-518. doi: 10.1080/09513590.2020.1793941. Epub 2020 Jul 15.
- Background: PubMed 31502111Ranisavljevic N, Raad J, Anahory T, Grynberg M, Sonigo C. Embryo transfer strategy and therapeutic options in infertile patients with thin endometrium: a systematic review. J Assist Reprod Genet. 2019 Nov;36(11):2217-2231. doi: 10.1007/s10815-019-01576-w. Epub 2019 Sep 9.
- Background: PubMed 21880274Paulson RJ. Hormonal induction of endometrial receptivity. Fertil Steril. 2011 Sep;96(3):530-5. doi: 10.1016/j.fertnstert.2011.07.1097.
- Background: PubMed 29675488Shahrokh Tehraninejad E, Kabodmehri R, Hosein Rashidi B, Jafarabadi M, Keikha F, Masomi M, Hagholahi F. Trans dermal estrogen (oestrogel) for endometrial preparation in freeze embryo transfer cycle: An RCT. Int J Reprod Biomed. 2018 Jan;16(1):51-56.
- Individual participant dataSharing planned: Yes. IPD will be shared with other researchers after publication of primary results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 17-beta Estradiol gel 0.06% w/w(ESTOGEL.Intas pharma) and Estradiol Hemihydrate(Estrabet Tablet, abbott pharma) in people with Frozen Embryo Transfer and Infertility, Female, run by Indira IVF Hospital Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: As per institutional protocol unable to recruit adequate number of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial thickness (ET) (time frame: 14 to 21 days after start of estrogen). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05802303, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.