Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-01-01 @ 7:18 PM
Study NCT ID:
NCT01007851
Status:
TERMINATED
Last Update Posted:
2009-11-04
First Post:
2009-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Dose Gonadotropin-releasing Hormone (GnRH) Agonist Administration in the Luteal Phase of GnRH Antagonist Stimulated ICSI-ET Cycles
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017329', 'term': 'Triptorelin Pamoate'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'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'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'whyStopped': 'Lower than anticipated recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-03', 'studyFirstSubmitDate': '2009-11-03', 'studyFirstSubmitQcDate': '2009-11-03', 'lastUpdatePostDateStruct': {'date': '2009-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ongoing pregnancy beyond 20th gestational week'}], 'secondaryOutcomes': [{'measure': 'clinical pregnancy rate'}, {'measure': 'Embryo implantation rate'}]}, 'conditionsModule': {'keywords': ['GnRH agonist', 'GnRH antagonist', 'IVF', 'ICSI', 'assisted reproduction', 'luteal phase'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'GnRH agonist administration in the luteal phase was reported to beneficially affect clinical outcome of ICSI-ET cycles. This randomized controlled trial evaluates the effect of a single dose GnRH agonist administered in the luteal phase on the outcome of ICSI - ET cycles stimulated with the fixed GnRH antagonist protocol. Women undergoing embryo transfer following controlled ovarian hyperstimulation with a fixed GnRH antagonist protocol were included. In addition to routine luteal phase support with progesterone women were randomized to receive a single dose of GnRH agonist or placebo on the sixth day after ICSI.Ongoing pregnancy rate was the primary outcome measure.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women undergoing embryo transfer following controlled ovarian hyperstimulation with a fixed GnRH antagonist protocol, oocyte pick-up and ICSI.\n* Embryo transfer performed on day 3\n\nExclusion Criteria:\n\n* Participation in another trial that was being conducted in our unit at the same time.\n* Preimplantation genetic screening cycles.\n* Day 5 embryo transfers.'}, 'identificationModule': {'nctId': 'NCT01007851', 'briefTitle': 'Single Dose Gonadotropin-releasing Hormone (GnRH) Agonist Administration in the Luteal Phase of GnRH Antagonist Stimulated ICSI-ET Cycles', 'organization': {'class': 'OTHER', 'fullName': 'V.K.V. American Hospital, Istanbul'}, 'orgStudyIdInfo': {'id': 'AH-48/07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GnRH agonist', 'interventionNames': ['Drug: triptorelin acetate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'interventionNames': ['Drug: NaCl %0.9']}], 'interventions': [{'name': 'triptorelin acetate', 'type': 'DRUG', 'description': 'single dose of 0.1 mg triptorelin subcutaneous injection on the 3rd day after embryo transfer', 'armGroupLabels': ['GnRH agonist']}, {'name': 'NaCl %0.9', 'type': 'DRUG', 'description': '0.1 ml sterile saline sc injection 3 days after embryo transfer', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34365', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'American Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'V.K.V. American Hospital, Istanbul', 'class': 'OTHER'}}}}