Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-02-25 @ 3:36 AM
Study NCT ID:
NCT02144818
Status:
UNKNOWN
Last Update Posted:
2014-05-22
First Post:
2014-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GnRH Agonist Triggering Supplemented With Hcg in Women With Poor Ovarian Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-19', 'studyFirstSubmitDate': '2014-04-28', 'studyFirstSubmitQcDate': '2014-05-19', 'lastUpdatePostDateStruct': {'date': '2014-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The main outcome is the number of mature oocytes', 'timeFrame': 'up to 12 months'}, {'measure': 'number of embryos appropriate for transfer', 'timeFrame': 'up to 12 month'}], 'secondaryOutcomes': [{'measure': 'pregnancy rate', 'timeFrame': 'up to 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Women With Poor Ovarian Response']}, 'descriptionModule': {'briefSummary': 'During the last decades, owing to the growing tendency of women to delay childbearing plans because of career and personal priorities, fertility specialists today are seeing more and more women with poor ovarian reserve and with poor ovarian response Controlled ovarian hyperstimulation (COH) is considered a important factor in the success of in vitro fertilization-embryo transfer (IVF-ET), enabling the recruitment of multiple oocytes and, thereby, resulting in more than one embryo. However, owing to the extreme variability in ovarian response to COH, in a subgroup of patients with poor ovarian response, this method may yield a very small number of follicles After succeeding in maximal recruitment of the follicles, the triggering of ovulation is extremely important in order to achieve, as many as, mature oocytes.\n\nSeveral studies have reported retrieval of more mature oocytes after GnRH agonist triggering compared to the number of oocytes retrieved after hCG. Among the possible advantages of GnRH agonist for final oocyte maturation is the simultaneous induction of an FSH surge. The role of the natural mid-cycle FSH surge is not fully clear. FSH was reported to induce LH receptor formation in luteinizing granulosa cells, and to promote oocyte nuclear maturation and cumulus expansion .\n\nAnother method described to trigger ovulation is the "Dual triggering"- GnRH agonist 40 h prior to ovum pickup and hCG added 6 h after the first trigger. The dual triggering was described as the treatment in cases with recurrent empty follicles.\n\nThe aim of the present study is to evaluate three different methods of ovulation triggering in women with poor ovarian response', 'detailedDescription': 'Inclusion criteria:\n\n* Women with low ovarian response according to the Bologna criteria, undergoing IVF treatments for this cause.\n\nExclusion criteria:\n\n* Women with good ovarian response.\n* Women with low ovarian response who are carriers of fragile X'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with low ovarian response according to the Bologna criteria, undergoing IVF treatments for this cause.\n\nExclusion Criteria:\n\n* Women with good ovarian response.\n* Women with low ovarian response who are carriers of fragile X'}, 'identificationModule': {'nctId': 'NCT02144818', 'briefTitle': 'GnRH Agonist Triggering Supplemented With Hcg in Women With Poor Ovarian Response', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'GnRH Agonist Triggering Supplemented With Hcg in Women With Poor Ovarian', 'orgStudyIdInfo': {'id': 'SHEBA-13-0438-JH-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GnRH agonist', 'interventionNames': ['Drug: Decapeptyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'hCG', 'interventionNames': ['Drug: Ovitrel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dual triggering: GnRH agonist and hCG', 'interventionNames': ['Drug: Ovitrel', 'Drug: Decapeptyl']}], 'interventions': [{'name': 'Ovitrel', 'type': 'DRUG', 'description': 'Triggering of ovulation with Ovitrel', 'armGroupLabels': ['dual triggering: GnRH agonist and hCG', 'hCG']}, {'name': 'Decapeptyl', 'type': 'DRUG', 'description': 'Triggering with GnRH agonist', 'armGroupLabels': ['GnRH agonist', 'dual triggering: GnRH agonist and hCG']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Jigal Haas, M.D', 'role': 'CONTACT', 'email': 'jigalh@hotmail.com', 'phone': '0972524651054'}, {'name': 'Jigal Haas, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sheba medical center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Gynecologist and Obstetrician', 'investigatorFullName': 'Dr. Jigal Haas MD', 'investigatorAffiliation': 'Sheba Medical Center'}}}}