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As per institutional protocol unable to recruit adequate number of patients
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transdermal Gel | Active Comparator | In the Estradiol gel group patients will be administered transdermal Estradiol gel (17-beta Estradiol gel 0.06%) |
|
| Oral Estradiol | Other | In the Oral Estradiol group, all women will be given oral Estradiol valerate tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Endometrial thickness (ET) | Average endometrial thickness achieved on day 14 of HRT | 14 to 21 days after start of estrogen |
| Measure | Description | Time Frame |
|---|---|---|
| Cycle cancelation rate | Number of cycles cancelled before embryo transfer × 100 | 21 days after starting HRT |
| Average E2 consumption | Total E2 consumed till embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Undesirable side effects between both the groups | Symptoms like rash, itching ,burning, thromboembolic event | Till 12 weeks of pregnancy |
Inclusion Criteria:
Exclusion Criteria:
All women planned for Frozen embryo transfer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indira IVF Hospital Private Limited | Udaipur | Rajasthan | 313001 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29529202 | Background | 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. | |
| 32991118 | Background |
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IPD will be shared with other researchers after publication of primary results
After 6 months of publication of primary results
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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All cases undergoing frozen embryo transfer with own or donor gametes.
| 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. |
|
| 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. | 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 | 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 . | Within 20 weeks of gestation |
| Patient satisfaction score | It is measured using visual analogue scale(VAS) score | on 1 day of embryo transfer |
| Scheffer 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. |
| 31969591 | Background | Corroenne 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. |
| 10098476 | Background | Devroey 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. |
| 32666854 | Background | Garimella 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. |
| 31502111 | Background | Ranisavljevic 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. |
| 21880274 | Background | Paulson RJ. Hormonal induction of endometrial receptivity. Fertil Steril. 2011 Sep;96(3):530-5. doi: 10.1016/j.fertnstert.2011.07.1097. |
| 29675488 | Background | Shahrokh 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. |
| D000091662 | Genital Diseases |
| D007246 | Infertility |