Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 1:02 AM
Study NCT ID:
NCT05969834
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2023-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HCG Levels After Ovulation Triggering as Predictors of ICSI Outcome
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': 'D006063', 'term': 'Chorionic Gonadotropin'}, {'id': 'D017329', 'term': 'Triptorelin Pamoate'}], 'ancestors': [{'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011257', 'term': 'Pregnancy Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-31', 'studyFirstSubmitDate': '2023-07-24', 'studyFirstSubmitQcDate': '2023-07-31', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '6 weeks after embryo transfer', 'description': 'Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures'}], 'secondaryOutcomes': [{'measure': 'Oocyte maturation rate', 'timeFrame': 'On 1 day of oocyte retrieval', 'description': 'Number of mature oocytes divided by the number of retrieved oocytes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ovulation triggering', 'uHCG', 'rHCG', 'GnRH', 'Dual trigger'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'This study aimed to assess the correlation between HCG levels after ovulation triggering and ICSI outcomes, affected by HCG formulation and dose', 'detailedDescription': 'The aims of this study are:\n\n1. To assess the correlation between serum human chorionic gonadotropin (hCG) level after ovulation triggering and intracytoplasmic sperm injection (ICSI) outcome including: oocyte maturity and quality, good quality embryo rate, blastocyst formation rate and pregnancy rate\n2. To determine if there is an association between type and dose of the trigger and ICSI outcome.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women who will undergo controlled ovarian stimulation (COS) through fixed GnRH antagonist protocol with ovulation triggering, according to the risk of OHSS, by: 1) urinary HCG (uHCG); 2) recombinant HCG (rHCG); or 3) a combination of GnRHa and HCG (dual trigger)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who will undergo controlled ovarian stimulation (COS) through fixed GnRH antagonist protocol\n\nExclusion Criteria:\n\n* BMI \\> 30 kg/m2\n* Irregular menstruation\n* Severe male factor abnormality\n* Poor ovarian reserve\n* Endometriosis\n* Uterine abnormality'}, 'identificationModule': {'nctId': 'NCT05969834', 'briefTitle': 'HCG Levels After Ovulation Triggering as Predictors of ICSI Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Human Chorionic Gonadotropin Levels After Ovulation Triggering as Predictors of Intracytoplasmic Sperm Injection Outcome', 'orgStudyIdInfo': {'id': 'MD.20.09.370'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'uHCG group', 'description': 'Trigger intramuscular (IM) administration of 10000 IU of uHCG', 'interventionNames': ['Drug: uHCG']}, {'label': 'rHCG group', 'description': 'Trigger with subcutaneous (SC) administration of 6500 IU of rHCG', 'interventionNames': ['Drug: rHCG']}, {'label': 'Dual trigger group', 'description': 'Combined SC administration of 0.1 mg of GnRHa and IM administration of 2500 IU of uHCG', 'interventionNames': ['Drug: uHCG and GnRHa']}], 'interventions': [{'name': 'uHCG', 'type': 'DRUG', 'otherNames': ['Choriomon'], 'description': 'Final oocyte maturation will be triggered by IM administration of 10000 IU of uHCG (Choriomon)', 'armGroupLabels': ['uHCG group']}, {'name': 'rHCG', 'type': 'DRUG', 'otherNames': ['Ovitrelle'], 'description': 'Final oocyte maturation will be triggered by SC administration of 6500 IU of rHCG (Ovitrelle)', 'armGroupLabels': ['rHCG group']}, {'name': 'uHCG and GnRHa', 'type': 'DRUG', 'otherNames': ['Decapeptyl and Choriomon'], 'description': 'Final oocyte maturation will be triggered by combined SC administration of 0.1 mg of GnRHa (Decapeptyl, Triptorelin) and IM administration of 2500 IU of uHCG (Choriomon)', 'armGroupLabels': ['Dual trigger group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Royal Center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Engy Abdallah, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University'}, {'name': 'Mohamed S Abdelhafez, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University'}, {'name': 'Mohamed Elzayat, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Royal Center'}, {'name': 'Amoura Abou-ElNaga, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}