Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT06165367
Status:
RECRUITING
Last Update Posted:
2025-03-12
First Post:
2023-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hyaluronan-enriched Medium and Euploid Blastocyst Transfers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'The study will be double-blinded (blinded to patient and doctor performing transfer).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization will be stratified according to the in-house embryo prognosis classification. Our internal data shows top quality embryos have 65% ongoing pregnancy rate and good quality embryos have 55% ongoing pregnancy rate. We assume a 20% relative increase over the baseline with the intervention which corresponds to 78% and 66% ongoing pregnancy rates for top and good quality euploid embryos, respectively. Total sample size requires in each group corresponds to 295 and 488 transfers of top and good quality embryos for a total of 783. Two interim analyses are planned when 35% (n=274) and 70% (n=548) of the target sample size is achieved to calculate conditional power. If conditional power is estimated to be lower than 15% at first interim analysis or lower than 30% in the second interim analysis, the trial will be stopped due to futility.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 783}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2023-11-22', 'studyFirstSubmitQcDate': '2023-12-08', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live birth rate (LBR)', 'timeFrame': '41 weeks', 'description': 'Defined as the delivery if a live infant born after 24 completed weeks of gestation'}], 'secondaryOutcomes': [{'measure': 'human chorionic gonadotropin (hCG) positiveness', 'timeFrame': '10-12 days after embryo transfer', 'description': 'hCG pregnancy test checks human chorionic gonadotropin (HCG) levels in the blood.'}, {'measure': 'Clinical pregnancy rate', 'timeFrame': '6 weeks', 'description': 'ultrasonographic sac visible at 5 gestational weeks'}, {'measure': 'Clinical miscarriage rate', 'timeFrame': '24 weeks', 'description': 'spontaneous loss of a clinical pregnancy before 24 weeks of gestation'}, {'measure': 'Ongoing pregnancy rate after 12 weeks', 'timeFrame': '13 weeks', 'description': 'viable pregnancy with gestational age more than 12 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HRT', 'PGT-A', 'Next-generation sequencing (NGS)', 'Miscarriage rate', 'single embryo transfer (SET)', 'EmbryoGlue', 'BMI', 'Embryo quality', 'Hyaluronan-enriched medium', 'Transfer medium'], 'conditions': ['Infertility', 'Implantation Rate', 'Clinical Pregnancy Rate', 'Live Birth Rate', 'Blastocysts', 'FET']}, 'referencesModule': {'references': [{'pmid': '10527990', 'type': 'BACKGROUND', 'citation': 'Gardner DK, Rodriegez-Martinez H, Lane M. Fetal development after transfer is increased by replacing protein with the glycosaminoglycan hyaluronan for mouse embryo culture and transfer. Hum Reprod. 1999 Oct;14(10):2575-80. doi: 10.1093/humrep/14.10.2575.'}, {'pmid': '12090927', 'type': 'BACKGROUND', 'citation': 'Stojkovic M, Kolle S, Peinl S, Stojkovic P, Zakhartchenko V, Thompson JG, Wenigerkind H, Reichenbach HD, Sinowatz F, Wolf E. Effects of high concentrations of hyaluronan in culture medium on development and survival rates of fresh and frozen-thawed bovine embryos produced in vitro. Reproduction. 2002 Jul;124(1):141-53.'}, {'pmid': '16727484', 'type': 'BACKGROUND', 'citation': 'Miyano T, Hiro-Oka RE, Kano K, Miyake M, Kusunoki H, Kato S. Effects of hyaluronic acid on the development of 1- and 2-cell porcine embryos to the blastocyst stage in vitro. Theriogenology. 1994;41(6):1299-305. doi: 10.1016/0093-691x(94)90488-5.'}, {'type': 'BACKGROUND', 'citation': 'Schoolcraft W, Lane M, Stevens J, Gardner D. Increased hyaluronannan concentration in the embryo transfer medium results in a signifcant increase in human embryo implantation rate. In American Society for Reproductive Medicine. 2002 Fertility and Sterility'}, {'pmid': '34034352', 'type': 'BACKGROUND', 'citation': 'Atkinson B, Woodland E. Embryo Glue: The Use of Hyaluronan in Embryo Transfer Media. Semin Reprod Med. 2021 Mar;39(1-02):24-26. doi: 10.1055/s-0041-1730415. Epub 2021 May 25.'}, {'pmid': '16786421', 'type': 'BACKGROUND', 'citation': 'Valojerdi MR, Karimian L, Yazdi PE, Gilani MA, Madani T, Baghestani AR. Efficacy of a human embryo transfer medium: a prospective, randomized clinical trial study. J Assist Reprod Genet. 2006 May;23(5):207-12. doi: 10.1007/s10815-006-9031-7. Epub 2006 Jun 20.'}, {'pmid': '17936283', 'type': 'BACKGROUND', 'citation': 'Urman B, Yakin K, Ata B, Isiklar A, Balaban B. Effect of hyaluronan-enriched transfer medium on implantation and pregnancy rates after day 3 and day 5 embryo transfers: a prospective randomized study. Fertil Steril. 2008 Sep;90(3):604-12. doi: 10.1016/j.fertnstert.2007.07.1294. Epub 2007 Oct 23.'}, {'pmid': '17765233', 'type': 'BACKGROUND', 'citation': 'Hazlett WD, Meyer LR, Nasta TE, Mangan PA, Karande VC. Impact of EmbryoGlue as the embryo transfer medium. Fertil Steril. 2008 Jul;90(1):214-6. doi: 10.1016/j.fertnstert.2007.05.063. Epub 2007 Sep 4.'}, {'pmid': '25151028', 'type': 'BACKGROUND', 'citation': 'Safari S, Razi MH, Safari S, Razi Y. Routine use of EmbryoGlue((R)) as embryo transfer medium does not improve the ART outcomes. Arch Gynecol Obstet. 2015 Feb;291(2):433-7. doi: 10.1007/s00404-014-3416-0. Epub 2014 Aug 24.'}, {'pmid': '32876946', 'type': 'BACKGROUND', 'citation': 'Heymann D, Vidal L, Or Y, Shoham Z. Hyaluronic acid in embryo transfer media for assisted reproductive technologies. Cochrane Database Syst Rev. 2020 Sep 2;9(9):CD007421. doi: 10.1002/14651858.CD007421.pub4.'}, {'type': 'BACKGROUND', 'citation': 'Child et al. A rCT assessing effectiveness of embryoglue in IVF transfer cycles. ASRM abstract 2021.'}, {'pmid': '33718621', 'type': 'BACKGROUND', 'citation': 'Adeniyi T, Horne G, Ruane PT, Brison DR, Roberts SA. Clinical efficacy of hyaluronate-containing embryo transfer medium in IVF/ICSI treatment cycles: a cohort study. Hum Reprod Open. 2021 Mar 3;2021(1):hoab004. doi: 10.1093/hropen/hoab004. eCollection 2021.'}, {'type': 'BACKGROUND', 'citation': 'Good practice for recommendation for add-ons in reproductive medicine. ESHRE-working group, 2023.'}, {'pmid': '24812313', 'type': 'BACKGROUND', 'citation': 'Oron G, Son WY, Buckett W, Tulandi T, Holzer H. The association between embryo quality and perinatal outcome of singletons born after single embryo transfers: a pilot study. Hum Reprod. 2014 Jul;29(7):1444-51. doi: 10.1093/humrep/deu079. Epub 2014 May 8.'}, {'pmid': '31165389', 'type': 'BACKGROUND', 'citation': 'Vinals Gonzalez X, Odia R, Naja R, Serhal P, Saab W, Seshadri S, Ben-Nagi J. Euploid blastocysts implant irrespective of their morphology after NGS-(PGT-A) testing in advanced maternal age patients. J Assist Reprod Genet. 2019 Aug;36(8):1623-1629. doi: 10.1007/s10815-019-01496-9. Epub 2019 Jun 4.'}, {'pmid': '24578475', 'type': 'BACKGROUND', 'citation': 'Capalbo A, Rienzi L, Cimadomo D, Maggiulli R, Elliott T, Wright G, Nagy ZP, Ubaldi FM. Correlation between standard blastocyst morphology, euploidy and implantation: an observational study in two centers involving 956 screened blastocysts. Hum Reprod. 2014 Jun;29(6):1173-81. doi: 10.1093/humrep/deu033. Epub 2014 Feb 26.'}, {'pmid': '28069172', 'type': 'BACKGROUND', 'citation': 'Irani M, Reichman D, Robles A, Melnick A, Davis O, Zaninovic N, Xu K, Rosenwaks Z. Morphologic grading of euploid blastocysts influences implantation and ongoing pregnancy rates. Fertil Steril. 2017 Mar;107(3):664-670. doi: 10.1016/j.fertnstert.2016.11.012. Epub 2017 Jan 6.'}, {'pmid': '35498424', 'type': 'BACKGROUND', 'citation': 'Li N, Guan Y, Ren B, Zhang Y, Du Y, Kong H, Zhang Y, Lou H. Effect of Blastocyst Morphology and Developmental Rate on Euploidy and Live Birth Rates in Preimplantation Genetic Testing for Aneuploidy Cycles With Single-Embryo Transfer. Front Endocrinol (Lausanne). 2022 Apr 13;13:858042. doi: 10.3389/fendo.2022.858042. eCollection 2022.'}, {'pmid': '36244848', 'type': 'BACKGROUND', 'citation': 'Xiao Y, Wang X, Gui T, Tao T, Xiong W. Transfer of a poor-quality along with a good-quality embryo on in vitro fertilization/intracytoplasmic sperm injection-embryo transfer clinical outcomes: a systematic review and meta-analysis. Fertil Steril. 2022 Dec;118(6):1066-1079. doi: 10.1016/j.fertnstert.2022.08.848. Epub 2022 Oct 14.'}, {'pmid': '24503642', 'type': 'BACKGROUND', 'citation': 'Brosens JJ, Salker MS, Teklenburg G, Nautiyal J, Salter S, Lucas ES, Steel JH, Christian M, Chan YW, Boomsma CM, Moore JD, Hartshorne GM, Sucurovic S, Mulac-Jericevic B, Heijnen CJ, Quenby S, Koerkamp MJ, Holstege FC, Shmygol A, Macklon NS. Uterine selection of human embryos at implantation. Sci Rep. 2014 Feb 6;4:3894. doi: 10.1038/srep03894.'}, {'type': 'BACKGROUND', 'citation': 'C. Jennison and B. W. Turnbull, "Group Sequential Methods with Applications to Clinical Trials," Chapman & Hall/CRC, Boca Raton, 2000.'}]}, 'descriptionModule': {'briefSummary': 'It has been proposed that enriching transfer media with hyaluronan (EmbryoGlue medium) improves pregnancy outcomes compared with media containing lower concentrations of this molecule. However, none of previous studies included preimplantation genetic testing for aneuploidy (PGT-A) embryos. In order to investigate the impact of this hyaluronan-enriched on pregnancy outcomes, it is essential to evaluate its efficacy on euploid-only embryo transfers. The aim of the present study is to evaluate whether a short period of exposure of euploid blastocysts to EmbryoGlue prior to and during transfer positively impact on pregnancy outcomes of frozen embryo transfer (FET) cycles.', 'detailedDescription': 'The study period will be determined by the completion of the predetermined sample size, with two interim analyses planned when 35% (n=274) and 70% (n=548) of the target sample size is achieved to calculate conditional power. If conditional power is estimated to be lower than 15% at first interim analysis or lower than 30% in the second interim analysis, the trial will be stopped due to futility. The study will be performed in Abu Dhabi-Fertility clinic. During the period of this prospective study, euploid blastocysts of enough quality that have been biopsied only on Day-5 for PGT-A, will be warmed for single blastocyst transfer. The patient´s endometrial preparation protocol for FET will be restricted to HRT only. The study will be double-blinded (blinded to patient and doctor performing transfer).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '46 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All frozen embryo transfer (FET) cycles with euploid blastocysts biopsied and vitrified on Day 5 after PGT-A.\n* Rank of randomization based on embryo quality.\n* Only hormonal replacement theraphy (HRT) cycle regimen.\n* Women aged 18 years to 46 years.\n* Having at least 1 chromosomally normal vitrified blastocyst(s) on Day 5 available for transfer.\n* All sperm samples.\n* BMI between 18 and 35.\n\nExclusion Criteria:\n\n* FET cycles with preimplantation genetic testing for monogenic disorders (PGT-M) and for structural rearrangements (PGT-SR).\n* FET cycles with mosaic / aneuploid blastocysts.\n* FET cycles with unknown outcome.\n* FET cycles with Day 6 or Day 7 biopsied blastocysts.\n* FET with patients' endometrium preparation with treatments other than HRT.\n* FET where PGT-A was performed for gender selection."}, 'identificationModule': {'nctId': 'NCT06165367', 'acronym': 'GluePloid', 'briefTitle': 'Hyaluronan-enriched Medium and Euploid Blastocyst Transfers', 'organization': {'class': 'OTHER', 'fullName': 'ART Fertility Clinics LLC'}, 'officialTitle': 'Impact of Hyaluronan-enriched Medium on Pregnancy Outcomes Following Euploid Blastocyst Transfers', 'orgStudyIdInfo': {'id': 'ART FERTILITY CLINICS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Blastocysts exposed to normal media (NEG)', 'description': 'Blastocysts exposed to routine-in use medium No intervention'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Blastocysts exposed to EmbryoGlue (EG)', 'description': 'Blastocysts exposed to EmbryoGlue', 'interventionNames': ['Drug: EmbryoGlue Medium']}], 'interventions': [{'name': 'EmbryoGlue Medium', 'type': 'DRUG', 'description': 'Embryos will be exposed to hyaluronic-enriched media (EmbryoGlue) before and during embryo transfer', 'armGroupLabels': ['Blastocysts exposed to EmbryoGlue (EG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60202', 'city': 'Abu Dhabi', 'state': 'Abu Dhabi Emirate', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'name': 'Barbara Lawrenz, PhD', 'role': 'CONTACT', 'email': 'barbara.lawrenz@artfertilityclinics.com', 'phone': '+971 800 337845489'}], 'facility': 'ART Fertility Clinics LLC', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}], 'centralContacts': [{'name': 'Daniela Nogueira', 'role': 'CONTACT', 'email': 'daniela.nogueira@artfertilityclinics.com', 'phone': '+971504374961'}, {'name': 'Jonalyn DV Edades, Nursing', 'role': 'CONTACT', 'email': 'jonalyn.edades@artfertilityclinics.com', 'phone': '+97152640866'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ART Fertility Clinics LLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Global Scientific Laboratory Director ART Fertility Clinics', 'investigatorFullName': 'Daniela Nogueira', 'investigatorAffiliation': 'ART Fertility Clinics LLC'}}}}