Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-25 @ 1:43 PM
Study NCT ID:
NCT07269392
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dual Trigger With HCG and GnRH Agonist on Thawed Modified Natural Cycle Embryo Transfer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}], 'ancestors': [{'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-09-21', 'studyFirstSubmitQcDate': '2025-12-05', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implantation', 'timeFrame': '14 days after embryo transfer', 'description': 'Implantation is defined as a positive serum β-hCG (\\>20 mIU/mL) measured 14 days after embryo transfer.'}], 'secondaryOutcomes': [{'measure': 'Clinical pregnancy', 'timeFrame': 'one week after confirm pregnancy', 'description': 'Clinical pregnancy is defined as visualization of a gestational sac on transvaginal ultrasonography one week after pregnancy has been confirmed.'}, {'measure': 'Ongoing pregnancy rate', 'timeFrame': '5 weeks after confirmed pregnancy', 'description': "An ongoing pregnancy is defined as a viable intrauterine pregnancy with fetal cardiac activity at ≥9 weeks' gestational age."}, {'measure': 'Miscarriage rate', 'timeFrame': 'before delivery'}, {'measure': 'Gestational age (weeks) at delivery', 'timeFrame': 'delivery', 'description': 'Gestational age (weeks) at delivery'}, {'measure': 'Live birth rate', 'timeFrame': 'delivery'}, {'measure': 'Birth weight', 'timeFrame': 'delivery', 'description': 'Birth weight of the bewborn (kg)'}, {'measure': 'Presence of significant congenital or medical conditions of the newborn', 'timeFrame': 'delivery', 'description': 'Presence of significant congenital or medical conditions of the newborn'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['In Vitro Fertilization (IVF)', 'Embryo Transfer']}, 'referencesModule': {'references': [{'pmid': '32563188', 'type': 'BACKGROUND', 'citation': 'Haas J, Bassil R, Samara N, Zilberberg E, Mehta C, Orvieto R, Casper RF. GnRH agonist and hCG (dual trigger) versus hCG trigger for final follicular maturation: a double-blinded, randomized controlled study. Hum Reprod. 2020 Jul 1;35(7):1648-1654. doi: 10.1093/humrep/deaa107.'}, {'pmid': '30609935', 'type': 'BACKGROUND', 'citation': 'Lin MH, Wu FS, Hwu YM, Lee RK, Li RS, Li SH. Dual trigger with gonadotropin releasing hormone agonist and human chorionic gonadotropin significantly improves live birth rate for women with diminished ovarian reserve. Reprod Biol Endocrinol. 2019 Jan 4;17(1):7. doi: 10.1186/s12958-018-0451-x.'}, {'pmid': '39229374', 'type': 'BACKGROUND', 'citation': 'Wang Y, Yi YC, Guu HF, Chen YF, Kung HF, Chang JC, Chen LY, Chuan ST, Chen MJ. GnRH agonist-only trigger, compared to dual trigger, reduces oocyte retrieval rate in high responders without affecting cumulative live birth rate. Front Endocrinol (Lausanne). 2024 Aug 20;15:1461317. doi: 10.3389/fendo.2024.1461317. eCollection 2024.'}, {'pmid': '35184525', 'type': 'BACKGROUND', 'citation': 'Halim B, Lubis HP. Dual trigger with gonadotropin-releasing hormone agonist and recombinant human chorionic gonadotropin improves the outcome of intrauterine insemination. Obstet Gynecol Sci. 2022 Mar;65(2):207-214. doi: 10.5468/ogs.21275. Epub 2022 Feb 21.'}, {'pmid': '37362090', 'type': 'BACKGROUND', 'citation': 'Yildirim Kopuk S, Ece Utkan Korun Z, Yuceturk A, Karaosmanoglu O, Yazicioglu C, Tiras B, Cakiroglu Y. Does dual trigger improve euploidy rate in normoresponder? A cross-sectional study. Int J Reprod Biomed. 2023 May 12;21(5):395-402. doi: 10.18502/ijrm.v21i5.13473. eCollection 2023 May.'}, {'pmid': '39549203', 'type': 'BACKGROUND', 'citation': 'He Z, Liu Y, Huang N, Liu X, Zeng L, Lian Y, Li R, Chi H. Dual trigger versus human chorionic gonadotropin trigger for blastocyst quality and cumulative live birth. J Assist Reprod Genet. 2024 Dec;41(12):3445-3453. doi: 10.1007/s10815-024-03293-5. Epub 2024 Nov 16.'}, {'pmid': '34059045', 'type': 'BACKGROUND', 'citation': 'Hu KL, Wang S, Ye X, Zhang D, Hunt S. GnRH agonist and hCG (dual trigger) versus hCG trigger for follicular maturation: a systematic review and meta-analysis of randomized trials. Reprod Biol Endocrinol. 2021 Jun 1;19(1):78. doi: 10.1186/s12958-021-00766-5.'}]}, 'descriptionModule': {'briefSummary': 'Impact of dual trigger using recombinant human chorionic gonadotropin (HCG) and gonadotropin-releasing hormone (GnRH) agonist on thawed modified natural cycle outcomes: an open-label multi-center randomized controlled trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. 24\\<= Age \\< 45 patient undergo mNC-FET\n\nExclusion Criteria:\n\n1\\. Congenital or acquired uterine abnormalities (uterine malformation, submucosal myoma, intrauterine adhesion or endometrial polyp \\>1cm)'}, 'identificationModule': {'nctId': 'NCT07269392', 'briefTitle': 'Dual Trigger With HCG and GnRH Agonist on Thawed Modified Natural Cycle Embryo Transfer', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Impact of Dual Trigger Using Recombinant Human Chorionic Gonadotropin (HCG) and Gonadotropin-releasing Hormone (GnRH) Agonist on Thawed Modified Natural Cycle Outcomes: an Open-label Multi-center Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '202409081MINB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dual', 'description': 'GnRH agonist', 'interventionNames': ['Drug: GnRH agonist']}, {'type': 'NO_INTERVENTION', 'label': 'hcg', 'description': 'hcg'}], 'interventions': [{'name': 'GnRH agonist', 'type': 'DRUG', 'description': 'GnRH agonist add to hcg for trigger', 'armGroupLabels': ['dual']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'william lee', 'role': 'CONTACT', 'email': 'wylee@ntuh.gov.tw', 'phone': '+886972652396'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}