Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-30 @ 8:15 AM
Study NCT ID:
NCT05362734
Status:
COMPLETED
Last Update Posted:
2023-07-07
First Post:
2022-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Freeze All Strategy Versus Fresh Embryo Transfer After GnRH Analogue Trigger
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016471', 'term': 'Ovarian Hyperstimulation Syndrome'}], 'ancestors': [{'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'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': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1396}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-06', 'studyFirstSubmitDate': '2022-05-02', 'studyFirstSubmitQcDate': '2022-05-02', 'lastUpdatePostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ongoing pregnancy rate', 'timeFrame': '8 years', 'description': 'number of viable pregnancies that had completed at least 12 weeks of gestation on the total number of ETs performed'}, {'measure': 'delivery rate', 'timeFrame': '8 years', 'description': 'number of deliveries of one or more live births over the total performed ET'}], 'secondaryOutcomes': [{'measure': 'Other pregnancy outcomes', 'timeFrame': '8 years', 'description': 'ectopic pregnancy rate, miscarriage rate, multiple Birth Rate'}, {'measure': 'Safety profile', 'timeFrame': '8 years', 'description': 'Severe ovarian hyperstimulation syndrome incidence'}, {'measure': 'the dropout rate', 'timeFrame': '8 years', 'description': 'number of cycles in which any live birth (from either ART and/or spontaneous conceive) was not achieved and still some embryos or oocytes had to be thawed'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Hyperstimulation Syndrome', 'Pregnancy Related']}, 'referencesModule': {'references': [{'pmid': '25069504', 'type': 'BACKGROUND', 'citation': "Kupka MS, Ferraretti AP, de Mouzon J, Erb K, D'Hooghe T, Castilla JA, Calhaz-Jorge C, De Geyter C, Goossens V; European IVF-Monitoring Consortium, for the European Society of Human Reproduction and Embryology. Assisted reproductive technology in Europe, 2010: results generated from European registers by ESHREdagger. Hum Reprod. 2014 Oct 10;29(10):2099-113. doi: 10.1093/humrep/deu175. Epub 2014 Jul 27."}, {'pmid': '27343272', 'type': 'BACKGROUND', 'citation': 'Humaidan P, Nelson SM, Devroey P, Coddington CC, Schwartz LB, Gordon K, Frattarelli JL, Tarlatzis BC, Fatemi HM, Lutjen P, Stegmann BJ. Ovarian hyperstimulation syndrome: review and new classification criteria for reporting in clinical trials. Hum Reprod. 2016 Sep;31(9):1997-2004. doi: 10.1093/humrep/dew149. Epub 2016 Jun 23.'}, {'pmid': '34644798', 'type': 'BACKGROUND', 'citation': 'Levi-Setti PE, Di Segni N, Gargasole C, Ronchetti C, Cirillo F. Ovarian Hyperstimulation: Diagnosis, Prevention, and Management. Semin Reprod Med. 2021 Nov;39(5-06):170-179. doi: 10.1055/s-0041-1736492. Epub 2021 Oct 13.'}, {'pmid': '32123753', 'type': 'BACKGROUND', 'citation': 'De Geyter C, Calhaz-Jorge C, Kupka MS, Wyns C, Mocanu E, Motrenko T, Scaravelli G, Smeenk J, Vidakovic S, Goossens V; European IVF-monitoring Consortium (EIM) for the European Society of Human Reproduction and Embryology (ESHRE). ART in Europe, 2015: results generated from European registries by ESHRE. Hum Reprod Open. 2020 Feb 24;2020(1):hoz038. doi: 10.1093/hropen/hoz038. eCollection 2020.'}, {'pmid': '21450755', 'type': 'BACKGROUND', 'citation': 'Humaidan P, Kol S, Papanikolaou EG; Copenhagen GnRH Agonist Triggering Workshop Group. GnRH agonist for triggering of final oocyte maturation: time for a change of practice? Hum Reprod Update. 2011 Jul-Aug;17(4):510-24. doi: 10.1093/humupd/dmr008. Epub 2011 Mar 30.'}, {'pmid': '15760966', 'type': 'BACKGROUND', 'citation': 'Humaidan P, Bredkjaer HE, Bungum L, Bungum M, Grondahl ML, Westergaard L, Andersen CY. GnRH agonist (buserelin) or hCG for ovulation induction in GnRH antagonist IVF/ICSI cycles: a prospective randomized study. Hum Reprod. 2005 May;20(5):1213-20. doi: 10.1093/humrep/deh765. Epub 2005 Mar 10.'}, {'pmid': '30855289', 'type': 'BACKGROUND', 'citation': 'Lawrenz B, Coughlan C, Fatemi HM. Individualized luteal phase support. Curr Opin Obstet Gynecol. 2019 Jun;31(3):177-182. doi: 10.1097/GCO.0000000000000530.'}, {'pmid': '29446481', 'type': 'BACKGROUND', 'citation': 'Abbara A, Islam R, Clarke SA, Jeffers L, Christopoulos G, Comninos AN, Salim R, Lavery SA, Vuong TNL, Humaidan P, Kelsey TW, Trew GH, Dhillo WS. Clinical parameters of ovarian hyperstimulation syndrome following different hormonal triggers of oocyte maturation in IVF treatment. Clin Endocrinol (Oxf). 2018 Jun;88(6):920-927. doi: 10.1111/cen.13569. Epub 2018 Mar 6.'}, {'pmid': '28760517', 'type': 'BACKGROUND', 'citation': 'Zegers-Hochschild F, Adamson GD, Dyer S, Racowsky C, de Mouzon J, Sokol R, Rienzi L, Sunde A, Schmidt L, Cooke ID, Simpson JL, van der Poel S. The International Glossary on Infertility and Fertility Care, 2017. Fertil Steril. 2017 Sep;108(3):393-406. doi: 10.1016/j.fertnstert.2017.06.005. Epub 2017 Jul 29.'}, {'pmid': '28784335', 'type': 'BACKGROUND', 'citation': 'ESHRE Special Interest Group of Embryology and Alpha Scientists in Reproductive Medicine. Electronic address: coticchio.biogenesi@grupposandonato.it. The Vienna consensus: report of an expert meeting on the development of ART laboratory performance indicators. Reprod Biomed Online. 2017 Nov;35(5):494-510. doi: 10.1016/j.rbmo.2017.06.015. Epub 2017 Aug 4.'}, {'pmid': '34250273', 'type': 'BACKGROUND', 'citation': "ESHRE Clinic PI Working Group; Vlaisavljevic V, Apter S, Capalbo A, D'Angelo A, Gianaroli L, Griesinger G, Kolibianakis EM, Lainas G, Mardesic T, Motrenko T, Pelkonen S, Romualdi D, Vermeulen N, Tilleman K. The Maribor consensus: report of an expert meeting on the development of performance indicators for clinical practice in ART. Hum Reprod Open. 2021 Jul 3;2021(3):hoab022. doi: 10.1093/hropen/hoab022. eCollection 2021."}, {'pmid': '22840239', 'type': 'BACKGROUND', 'citation': 'Tomas C, Alsbjerg B, Martikainen H, Humaidan P. Pregnancy loss after frozen-embryo transfer--a comparison of three protocols. Fertil Steril. 2012 Nov;98(5):1165-9. doi: 10.1016/j.fertnstert.2012.07.1058. Epub 2012 Jul 27.'}, {'pmid': '33354626', 'type': 'BACKGROUND', 'citation': 'ESHRE working group on Ectopic Pregnancy; Kirk E, Ankum P, Jakab A, Le Clef N, Ludwin A, Small R, Tellum T, Toyli M, Van den Bosch T, Jurkovic D. Terminology for describing normally sited and ectopic pregnancies on ultrasound: ESHRE recommendations for good practice. Hum Reprod Open. 2020 Dec 16;2020(4):hoaa055. doi: 10.1093/hropen/hoaa055. eCollection 2020.'}, {'pmid': '29232273', 'type': 'BACKGROUND', 'citation': 'Committee on Practice Bulletins-Gynecology. ACOG Practice Bulletin No. 191: Tubal Ectopic Pregnancy. Obstet Gynecol. 2018 Feb;131(2):e65-e77. doi: 10.1097/AOG.0000000000002464.'}, {'pmid': '32644107', 'type': 'BACKGROUND', 'citation': "Sunkara SK, Zheng W, D'Hooghe T, Longobardi S, Boivin J. Time as an outcome measure in fertility-related clinical studies: long-awaited. Hum Reprod. 2020 Aug 1;35(8):1732-1739. doi: 10.1093/humrep/deaa138."}]}, 'descriptionModule': {'briefSummary': 'Ovarian hyperstimulation syndrome (OHSS) is one of the most dangerous complications of assisted reproduction technology (ART), described in approximatively 3 to 10% of stimulation cycles although an underestimation of the real incidence has been suggested.\n\nThe use in clinical practice of GnRH antagonist has made it possible to perform the trigger with GnRH analogues, with the advantage of considerably reducing the risk of OHSS.', 'detailedDescription': 'The main concerns about the trigger with analogue are about obstetric outcomes, since it may increase the Abortion Rate (AR) and reduce the Ongoing Pregnancy Rate (OPR) due to luteal phase deficiency, and on the other hand about oocyte quality and competence.\n\nWhile in order to maximize the chance of pregnancy at fresh embryo transfer after GnRHa trigger, several studies have focused on the importance of luteal phase support, other authors suggest that the best strategy is freeze-all: cryopreservation of all the obtained embryos and subsequent single embryo transfers.\n\nHowever, data about oocyte quality, retrieval rate, pregnancy rate and reduced occurrence of complications such as OHSS, especially on the very first embryo transfer, are still scarce.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study database includes all Oocyte Retrievals (OR) performed between 01/01/2012 and 31/12/2020 at Humanitas Fertility Center after antagonist protocol stimulation and trigger with GnRH agonist.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing ART cycle with antagonist protocol stimulation and trigger with GnRH agonist\n* patients are believed at risk of OHSS at time of trigger based on size and number of follicles developed (≥18 follicles with diameter 12 mm at induction).\n\nExclusion Criteria:\n\n* hypogonadotropic hypogonadism\n* other ART protocols\n* any patient that underwent freeze-all strategy in order to perform pre-implantation genetic testing (PGT)\n* oncological or deferring motherhood freezing procedures'}, 'identificationModule': {'nctId': 'NCT05362734', 'briefTitle': 'Freeze All Strategy Versus Fresh Embryo Transfer After GnRH Analogue Trigger', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Clinico Humanitas'}, 'officialTitle': 'Freeze All Strategy Versus Fresh Embryo Transfer After GnRH Analogue Trigger', 'orgStudyIdInfo': {'id': '999'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'First fresh embryo transfer (group A)', 'description': 'The two groups analysed were defined according to the modality of first embryo transfer: cycles in which a fresh ET was performed at first, after a dual triggering or a rescue protocol (Group A) and cycles where a frozen-thawed ET was performed at first, after being chosen a freeze-all strategy (Group B).', 'interventionNames': ['Behavioral: obstetric outcomes after fresh versus cryopreserved embryo transfer']}, {'label': 'First cryopreserved embryo transfer (group B)', 'description': 'The two groups analysed were defined according to the modality of first embryo transfer: cycles in which a fresh ET was performed at first, after a dual triggering or a rescue protocol (Group A) and cycles where a frozen-thawed ET was performed at first, after being chosen a freeze-all strategy (Group B).', 'interventionNames': ['Behavioral: obstetric outcomes after fresh versus cryopreserved embryo transfer']}], 'interventions': [{'name': 'obstetric outcomes after fresh versus cryopreserved embryo transfer', 'type': 'BEHAVIORAL', 'description': 'measure of ongoing pregnancy rate, delivery rate, abortion rate, ectopic pregnancy rate, multiple birth rate, ovarian hyperstimulation syndrome incidence, drop out rate', 'armGroupLabels': ['First cryopreserved embryo transfer (group B)', 'First fresh embryo transfer (group A)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Clinico Humanitas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}