Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT04973969
Status:
UNKNOWN
Last Update Posted:
2021-07-22
First Post:
2021-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Follicular Challenge Test to Predict Response to GnRH Agonist Triggering
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'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': 'D007246', 'term': 'Infertility'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017329', 'term': 'Triptorelin Pamoate'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-21', 'studyFirstSubmitDate': '2021-06-13', 'studyFirstSubmitQcDate': '2021-07-21', 'lastUpdatePostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The response to GnRH triggering', 'timeFrame': 'One treatment cycle (each cycle is 28 days) for each participant (up to 28 days).', 'description': 'LH levels 10-12 hours after decapeptyl trigger, number of mature oocytes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility, Female']}, 'descriptionModule': {'briefSummary': 'GnRH agonist triggering is used during ART in order to reduce the risk of OHSS. Some studies described that in up to 5% of the cycles triggered with GnRH agonist, a lack of respone or suboptimal response was displayed.\n\nThe investigators aim to asses the possibility to predict the respone to ovulation triggering by the response to decapeptyl in the follicular phase of the same cycle.', 'detailedDescription': 'The investigators will use Decapeptyl on day 2 of menstruation followed by antagonist protocol.\n\nHormonal proflie including E2, P, LH, FSH will be measured. LH surge and the rest of the hormonal profile will be compared to day after ovulation triggering.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '41 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'Infertility patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients that undergo fertility preservation\n\n * patients planned to freeze embryos due to PGT or surrogacy --patients at high risk for OHSS\n\nExclusion Criteria:\n\n* Poor ovarian response\n* known hypothalamic- pituitary dysfunction'}, 'identificationModule': {'nctId': 'NCT04973969', 'briefTitle': 'Follicular Challenge Test to Predict Response to GnRH Agonist Triggering', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Follicular Challenge Test to Predict Response to GnRH Agonist Triggering', 'orgStudyIdInfo': {'id': '0304-20-ASF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'study group', 'description': 'The participants will recieve decapeptyl 0.2 mg on day 2/3 of the follicular phase.At that day, and at the day after, hormonsl profile will be documented. The hormonal profile of the day after follicular decapeptyl administration will be compared to the hormonal profile to test the predictive value.', 'interventionNames': ['Other: Decapeptyl']}], 'interventions': [{'name': 'Decapeptyl', 'type': 'OTHER', 'description': 'diagnosis of predictio value', 'armGroupLabels': ['study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tzrifin', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Sarit Avraham, Dr', 'role': 'CONTACT'}], 'facility': 'Shamir medical center', 'geoPoint': {'lat': 31.95649, 'lon': 34.84002}}], 'centralContacts': [{'name': 'Sarit Avraham, Dr', 'role': 'CONTACT', 'email': 'sarita@shamir.gov.il', 'phone': '00972522371126'}], 'overallOfficials': [{'name': 'Sarit Avraham, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asaf Harofe Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'senior physician', 'investigatorFullName': 'Assaf Harofeh MC', 'investigatorAffiliation': 'Assaf-Harofeh Medical Center'}}}}