Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT04224818
Status:
COMPLETED
Last Update Posted:
2021-07-23
First Post:
2019-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dual Trigger in the Final Oocyte Maturation in Poor Ovarian Responders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017329', 'term': 'Triptorelin Pamoate'}, {'id': 'D006063', 'term': 'Chorionic Gonadotropin'}], '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': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D011257', 'term': 'Pregnancy Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-19', 'studyFirstSubmitDate': '2019-09-20', 'studyFirstSubmitQcDate': '2020-01-08', 'lastUpdatePostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of oocytes retrieved (oocyte collection rate)', 'timeFrame': '38 hrs', 'description': 'the total number of oocytes retrieved divided by the number of follicles aspirated (diameter ≥10 mm) on the day of oocyte retrieval'}, {'measure': 'Number of mature oocytes (oocyte maturation rate)', 'timeFrame': '38 hrs', 'description': 'the ratio of MII oocytes to the number of collected oocytes'}], 'secondaryOutcomes': [{'measure': 'Fertilization rate', 'timeFrame': '48 hrs', 'description': 'the ratio of normal fertilized oocytes (2PN) to the number of oocytes used for fertilization'}, {'measure': 'Clinical pregnancy rate', 'timeFrame': '7 weeks', 'description': 'the presence of fetal cardiac activity confirmed by transvaginal ultrasound 7 weeks after embryo transfer'}, {'measure': 'Implantation rate', 'timeFrame': '7 weeks', 'description': 'the number of gestational sacs visualized on ultrasound examination divided by the number of embryos transferred'}, {'measure': 'Miscarriage rate', 'timeFrame': '12 weeks', 'description': 'the spontaneous loss of a clinical pregnancy occurring before 12 completed weeks of gestational age'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Poor Ovarian Reserve']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled clinical trial to investigate the effect of dual trigger (hCG and GnRH agonist) on the final oocyte maturation compared to the standard hCG trigger in patients with poor ovarian reserve seeking IVF/ICSI treatment.', 'detailedDescription': 'Women with POR (Bologna criteria) manifest a very low follicular response to controlled ovarian stimulation irrespective of the stimulation protocol utilized. Dual triggering of oocyte maturation was shown to improve follicle collection yield and oocyte maturation in women with predicted normal ovarian response. These benefits have been attributed to the GnRHa-induced FSH surge believed to promote oocyte nuclear maturation and cumulus expansion. The aim of the study is to show whether the co-administration of a GnRH agonist and hCG for final oocyte maturation improve oocyte collection and maturation rate'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal uterine cavity (as assessed by hysteroscopy or HSG).\n* Normal hormonal investigation: TSH, PRL.\n* Low ovarian reserve patients (AMH\\<1.5ng/ml, AFC of 7 or less, 5 oocytes or less retrieved in a previous cycle)\n\nExclusion Criteria:\n\n* Abnormal uterine cavity (Hysteroscopy or HSG)\n* Evidence of untreated endocrine disorders (abnormal TSH, prolactin, testosterone and androstenedione concentrations)'}, 'identificationModule': {'nctId': 'NCT04224818', 'briefTitle': 'Dual Trigger in the Final Oocyte Maturation in Poor Ovarian Responders', 'organization': {'class': 'OTHER', 'fullName': 'American University of Beirut Medical Center'}, 'officialTitle': 'Dual Trigger in the Final Oocyte Maturation in Poor Ovarian Responders: A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'BIO-2018-0020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dual trigger', 'description': 'Dual trigger: (0.3 mg GnRHa = triptorelin) with + HCG (Choriomon)10 000 IU . will be administered subcutaneously in a single dose 0.3 mg with 10 000 HCG when at least 2 follicles 18 mm in diameter have been observed by ultrasound examination.', 'interventionNames': ['Drug: Dual trigger']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'hCG (standard)', 'description': 'HCG (Choriomon) of 10 000 IU will be administered subcutaneously in a single dose when at least 2 follicles 18 mm in diameter have been observed by ultrasound examination.', 'interventionNames': ['Drug: hCG (standard)']}], 'interventions': [{'name': 'Dual trigger', 'type': 'DRUG', 'otherNames': ['Dual ovulation trigger (Choriomon and Triptorelin)'], 'description': 'Dual trigger: human Chorionic Gonadotropin (Choriomon 10,000 IU subcutaneous once) + Gonadotropin-Releasing Hormone agonist (Triptorelin 0.3 mg subcutaneous once)', 'armGroupLabels': ['Dual trigger']}, {'name': 'hCG (standard)', 'type': 'DRUG', 'otherNames': ['human Chorionic Gonadotropin'], 'description': 'human Chorionic Gonadotropin (Choriomon 10,000 IU subcutaneous once)', 'armGroupLabels': ['hCG (standard)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'country': 'Lebanon', 'facility': 'American University of Beirut Medical Center', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Ghina S Ghazeeri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American University of Beirut Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American University of Beirut Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}