Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
Study NCT ID:
NCT05802303
Status:
TERMINATED
Last Update Posted:
2024-03-28
First Post:
2023-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Estrogen (Gel)Transdermal vs Oral Estrogen for Endometrial Preparation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'All cases undergoing frozen embryo transfer with own or donor gametes.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}}, 'statusModule': {'whyStopped': 'As per institutional protocol unable to recruit adequate number of patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2023-02-21', 'studyFirstSubmitQcDate': '2023-04-04', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Undesirable side effects between both the groups', 'timeFrame': 'Till 12 weeks of pregnancy', 'description': 'Symptoms like rash, itching ,burning, thromboembolic event'}], 'primaryOutcomes': [{'measure': 'Endometrial thickness (ET)', 'timeFrame': '14 to 21 days after start of estrogen', 'description': 'Average endometrial thickness achieved on day 14 of HRT'}], 'secondaryOutcomes': [{'measure': 'Cycle cancelation rate', 'timeFrame': '21 days after starting HRT', 'description': 'Number of cycles cancelled before embryo transfer × 100'}, {'measure': 'Average E2 consumption', 'timeFrame': 'On 1 day of embryo transfer', 'description': 'Total E2 consumed till embryo transfer'}, {'measure': 'Implantation rates (IR)', 'timeFrame': '4 weeks + 2 weeks after embryo transfer', 'description': 'The number of gestational sacs observed by transvaginal ultrasound at the 6th gestational week per the number of embryos transferred.'}, {'measure': 'Clinical pregnancy rates (CPR)', 'timeFrame': '4 weeks + 2 weeks after embryo transfer', 'description': 'Detection of a foetal heartbeat on transvaginal ultrasound at the 6th gestational week per embryo transfer cycle'}, {'measure': 'Miscarriage rates (MR)', 'timeFrame': 'Within 20 weeks of gestation', 'description': 'Number of spontaneous pregnancy losses in which a gestational sac was previously observed (before gestation week \\<20 weeks) per 100 clinical pregnancy .'}, {'measure': 'Patient satisfaction score', 'timeFrame': 'on 1 day of embryo transfer', 'description': 'It is measured using visual analogue scale(VAS) score'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transdermal Estrogen', 'FET', 'Oral Estrogen', 'IVF/ICSI'], 'conditions': ['Frozen Embryo Transfer', 'Infertility, Female']}, 'referencesModule': {'references': [{'pmid': '29529202', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32991118', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31969591', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10098476', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32666854', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31502111', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21880274', 'type': 'BACKGROUND', 'citation': 'Paulson RJ. Hormonal induction of endometrial receptivity. Fertil Steril. 2011 Sep;96(3):530-5. doi: 10.1016/j.fertnstert.2011.07.1097.'}, {'pmid': '29675488', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'genderBased': True, 'genderDescription': 'All women planned for Frozen embryo transfer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infertile patients aged 23-35 years.\n* BMI 18.5 to 29.9 kg/m2.\n* A normal uterine cavity assessed by 3D ultrasound (USG)/hysteroscopy.\n* Patients who underwent IVF/ICSI and who have cryopreserved their embryos.\n* Those receiving donor oocytes or donor embryos.\n* Patients undergoing hormonal replacement frozen embryo transfer (HRT-FET) cycles with GnRH agonist suppression.\n* Embryo Transfers of good quality embryos -2/3/4/5 AA, AB, BA(As per Gardner Grading System).\n\nExclusion Criteria:\n\n* Preimplantation Genetic Testing for Aneuploidies (PGT-A) cycles.\n* Patients who had a FET performed in natural or stimulated cycles.\n* Patients who had more than 2 failed transfers due to thin endometrium.\n* Patients having uterine anomalies.\n* Known cases of adenomyosis and endometriosis.\n* Underlying cardiac/renal/hepatic/thromboembolic disorders, h/o anxiety or depression.\n* E2 \\>50 pg./ml, P4 \\> 1 ng/ml and on D2 of menses.\n* On D2 scan presence of a cyst or a dominant follicle.\n* Patients with a history of recurrent 1st-trimester abortions.'}, 'identificationModule': {'nctId': 'NCT05802303', 'briefTitle': 'Estrogen (Gel)Transdermal vs Oral Estrogen for Endometrial Preparation', 'organization': {'class': 'OTHER', 'fullName': 'Indira IVF Hospital Pvt Ltd'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'IIHPL-UDR/RCT/002_2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transdermal Gel', 'description': 'In the Estradiol gel group patients will be administered transdermal Estradiol gel (17-beta Estradiol gel 0.06%)', 'interventionNames': ['Drug: 17-beta Estradiol gel 0.06% w/w(ESTOGEL.Intas pharma)']}, {'type': 'OTHER', 'label': 'Oral Estradiol', 'description': 'In the Oral Estradiol group, all women will be given oral Estradiol valerate tablets', 'interventionNames': ['Drug: Estradiol Hemihydrate(Estrabet Tablet, abbott pharma)']}], 'interventions': [{'name': '17-beta Estradiol gel 0.06% w/w(ESTOGEL.Intas pharma)', 'type': 'DRUG', 'description': '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).', 'armGroupLabels': ['Transdermal Gel']}, {'name': 'Estradiol Hemihydrate(Estrabet Tablet, abbott pharma)', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Oral Estradiol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '313001', 'city': 'Udaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Indira IVF Hospital Private Limited', 'geoPoint': {'lat': 24.58584, 'lon': 73.71346}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'After 6 months of publication of primary results', 'ipdSharing': 'YES', 'description': 'IPD will be shared with other researchers after publication of primary results'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indira IVF Hospital Pvt Ltd', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Clinical Lab Operations', 'investigatorFullName': 'Dr Vipin Chandra', 'investigatorAffiliation': 'Indira IVF Hospital Pvt Ltd'}}}}