Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-27 @ 3:34 AM
Study NCT ID:
NCT05484193
Status:
UNKNOWN
Last Update Posted:
2022-08-02
First Post:
2022-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GnRH Agonist for Luteal Phase Support.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D017274', 'term': 'Nafarelin'}, {'id': 'D011374', 'term': 'Progesterone'}, {'id': 'C000624167', 'term': 'Utrogestan'}], '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'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-01', 'studyFirstSubmitDate': '2022-07-31', 'studyFirstSubmitQcDate': '2022-08-01', 'lastUpdatePostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pregnancy', 'timeFrame': '2 weeks', 'description': '\\- positive Bhcg'}], 'secondaryOutcomes': [{'measure': 'clinical pregnancy', 'timeFrame': '5 weeks', 'description': 'gestational sac with heartbeat'}, {'measure': 'ovarian hyperstimulation syndrome', 'timeFrame': '5 weeks', 'description': 'early and late'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Use of GnRH Agonist Alone for Luteal Phase Support in Fresh IVF Cycles']}, 'referencesModule': {'references': [{'pmid': '37186265', 'type': 'DERIVED', 'citation': 'Buhbut E, Nabulsi R, Avigdor G, Ben-Ami I. Comparison of pregnancy rates in antagonist cycles after luteal support with GnRH-agonist versus progesterone: prospective randomized study. Arch Gynecol Obstet. 2023 Jul;308(1):255-263. doi: 10.1007/s00404-023-07017-5. Epub 2023 Apr 25.'}]}, 'descriptionModule': {'briefSummary': 'Objective To assess the the efficacy of luteal support with GnRH agonist in patients undergoing IVF in antagonist-based hcg triggered cycles compared with standard luteal support with progesterone.\n\nDesign prospective randomized controled study Subjects Patients who underwent antagonist-based cycles performed in the "Shaare Zedek Medical Center" IVF clinic between 2020 and 2022 Intervention Intranasal GnRH-agonist or vaginal Progesterone for luteal support.\n\nMain outcome measures Pregnancy and clinical pregnancy rates, ohss.\n\nThe study cohort included 150 patients who underwent 164 cycles. A total of 127 cycles were included. Of them, 64 were treated with GnRH-a and 63 with progesterone.\n\nHypothesis: This RCT suggests that GnRH-a for luteal phase support is associated with a higher positive β-hCG pregnancy rate and clinical pregnancy rate, compared with standard progesterone support in an antagonist-based protocol triggered with hCG, while maintaining a similar safety profile.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:Criteria for inclusion were patients aged between 18-45 years, BMI between 19-35, infertility diagnosis of male factor, tubal factor, anovulation, unexplained and age-related. Patients with or without infertility diagnosis, who underwent IVF for PGT were also included.\n\n\\-\n\nExclusion Criteria:\n\nExclusion criteria were triggering with agents other than hCG, previous 3 or more failed cycles in which a good quality embryo or embryos were transferred, endometriosis, hydrosalpinx, hypogonadotropic hypogonadism, and Mullerian malformations. Drop-out criteria included no fresh embryo transfer, intolerance to GnRH-a, and nasal congestion during the luteal phase.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05484193', 'briefTitle': 'GnRH Agonist for Luteal Phase Support.', 'organization': {'class': 'OTHER', 'fullName': 'Shaare Zedek Medical Center'}, 'officialTitle': 'Comparison of Pregnancy Rates After Luteal Phase Support With GnRH Agonist Versus Progesterone - a Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'Synarel fresh LPS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GnRH-agonist group', 'description': 'In the GnRH-a group, LPS was initiated on the evening after the OPU, using Nafareline (Synarel nasal spray 200mg used once), followed by twice daily (total 400mg/day) until the day of serum β-hCG pregnancy test, and then stopped, regardless of the test results', 'interventionNames': ['Drug: GnRH agonist']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Progesterone group', 'description': 'In the progesterone group, LPS was initiated on the morning after OPU, using micronized progesterone ( PV Utrogestan 300mg, 3 times daily), until serum β-hCG pregnancy tests results were available. If a β-hCG pregnancy was confirmed, LPS was continued until the end of the 8th gestational week', 'interventionNames': ['Drug: Progesterone']}], 'interventions': [{'name': 'GnRH agonist', 'type': 'DRUG', 'otherNames': ['Synarel'], 'description': 'GnRH agonist alone for luteal phase support in fresh IVF embryo transfer cycles', 'armGroupLabels': ['GnRH-agonist group']}, {'name': 'Progesterone', 'type': 'DRUG', 'otherNames': ['Utrogestan'], 'description': 'vaginal progesterone for luteal phase support', 'armGroupLabels': ['Progesterone group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Shaare Zedek medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaare Zedek Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}