Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-03 @ 3:21 PM
Study NCT ID:
NCT03693534
Status:
UNKNOWN
Last Update Posted:
2020-10-08
First Post:
2018-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Live Birth Rates After Following Long Antagonist Protocol Versus Long Agonist Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065172', 'term': 'Pregnancy, Ovarian'}], 'ancestors': [{'id': 'D011271', 'term': 'Pregnancy, Ectopic'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2018-09-24', 'studyFirstSubmitQcDate': '2018-10-02', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Pregnancy Rate according to stimulation protocol', 'timeFrame': '6 weeks to 42 weeks after embryo transfer', 'description': 'Clinical Pregnancy Rate according to stimulation protocol'}, {'measure': 'Number of formed blastocysts in each group of patients', 'timeFrame': '5 days after the OPU day', 'description': 'The number of the formed blastocysts in each group of patients according to the COS protocol'}], 'secondaryOutcomes': [{'measure': 'Live Birth Rate according to stimulation protocol', 'timeFrame': '6 weeks to 42 weeks after embryo transfer', 'description': 'Live Birth Rate according to stimulation protocol'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Long Antagonist', 'Long agonist', 'clinical pregnancy rate', 'live birth rate', 'ovarian stimulation', 'IVF'], 'conditions': ['Pregnancy, Ovarian']}, 'descriptionModule': {'briefSummary': 'A prospective study of the evaluation of the clinical IVF (in vitro fertilization) results after following Long Antagonist protocol for Controlled Ovarian Stimulation (COS) versus following Long Agonist protocol', 'detailedDescription': 'A prospective study of the clinical results in women who followed the Long Antagonist protocol for Controlled Ovarian Stimulation (COS) versus women who followed Long Agonist protocol, in an In Vitro Fertilization (IVF) try. In particular, the Clinical Pregnancy Rates (CPR) and Live Birth Rates (LBR) were estimated for the two groups of patients. The number of the formed blastocysts was also measured in each group of patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women 18- 39 years old who follow COS with the Long Antagonist Protocol or with Long Agonist Protocol', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* primary infertility\n* age 18-39 years; body mass index (BMI) 18-29kg/m2;\n* regular menstrual cycle of 26-35days,\n* presumed to be ovulatory;\n* early follicular- phase serum concentration of FSH within normal limits (1-12 IU/l).\n\nExclusion Criteria:\n\n* women with diabetes and other metabolic disease\n* women with heart disease, QT prolongation,heart failure\n* elevated liver enzymes, liver failure, hepatitis\n* women with inflammatory or autoimmune disease\n* abnormal karyotype;\n* polycystic ovarian syndrome,\n* endometriosis stage III/IV;\n* history of being a 'poor responder',\n* defined as \\>20 days of gonadotrophin in a previous stimulation cycle, or any previous cancellation of a stimulation cycle due to limited follicular response, or development of less than 4 follicles 15 mm in a previous stimulation cycle; history of recurrent miscarriage; severe OHSS in a previous stimula- tion cycle or any contraindication for the use of gonadotrophins."}, 'identificationModule': {'nctId': 'NCT03693534', 'briefTitle': 'Clinical and Live Birth Rates After Following Long Antagonist Protocol Versus Long Agonist Protocol', 'organization': {'class': 'OTHER', 'fullName': 'Assisting Nature'}, 'officialTitle': 'Clinical and Live Birth Rates After Controlled Ovarian Stimulation With the Long Antagonist Protocol Versus the Long Agonist Protocol', 'orgStudyIdInfo': {'id': 'Long-Antagonist-AN005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Long Antagonist Protocol', 'description': 'Clinical Pregnancy Rate, Live Birth Rate and Blastulation Rate of patients who followed Long Antagonist Protocol for Controlled Ovarian Stimulation.', 'interventionNames': ['Diagnostic Test: Clinical Pregnancy Rate']}, {'label': 'Long Agonist Protocol', 'description': 'Clinical Pregnancy Rate and Live Birth Rates and Blastulation Rate of patients who followed Long Agonist Protocol for Controlled Ovarian Stimulation.', 'interventionNames': ['Diagnostic Test: Clinical Pregnancy Rate']}], 'interventions': [{'name': 'Clinical Pregnancy Rate', 'type': 'DIAGNOSTIC_TEST', 'description': 'The Clinical Pregnancy, Live Birth Rate and Blastulation Rate according to the protocol of COS', 'armGroupLabels': ['Long Agonist Protocol', 'Long Antagonist Protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57001', 'city': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Evaggelos Papanikolaou, MD, PhD', 'role': 'CONTACT', 'email': 'papanikolaou@assistingnature.gr', 'phone': '00302310424294'}, {'name': 'Robert Najdecki, MD, PhD', 'role': 'CONTACT', 'email': 'rnajdecki@assistingnature.gr', 'phone': '00306936646464'}], 'facility': 'Assisting Nature', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'centralContacts': [{'name': 'Evaggelos Papanikolaou, MD,PhD', 'role': 'CONTACT', 'email': 'drvagpapanikolaou@yahoo.gr', 'phone': '00302310424294'}], 'overallOfficials': [{'name': 'Evaggelos Papanikolaou, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assisting Nature'}, {'name': 'Robert Najdecki, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assisting Nature'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assisting Nature', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Papanikolaou Evaggelos, MD, PhD, Fertility Specialist, Scientific Director at Assisting Nature IVF Clinic', 'investigatorFullName': 'Papanikolaou Evaggelos', 'investigatorAffiliation': 'Assisting Nature'}}}}