Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-30 @ 6:36 AM
Study NCT ID:
NCT01319708
Status:
COMPLETED
Last Update Posted:
2015-11-10
First Post:
2011-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mild Versus Conventional Ovarian Stimulation for Poor Responders Undergoing In Vitro Fertilisation
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-07', 'studyFirstSubmitDate': '2011-03-08', 'studyFirstSubmitQcDate': '2011-03-21', 'lastUpdatePostDateStruct': {'date': '2015-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of oocytes (COCs)', 'timeFrame': 'at oocyte recovery'}], 'secondaryOutcomes': [{'measure': 'Number/rate of participants whom the IVF cycle was cancelled', 'timeFrame': 'After the 1st week of ovarian stimulation, no oocytes at OR'}, {'measure': 'clinical pregnancy rate', 'timeFrame': '6 weeks', 'description': 'Presence of fetal heart at transvaginal ultrasound at 6 weeks of gestation or 6 weeks after starting the intervention'}, {'measure': 'live birth', 'timeFrame': 'more than 20 weeks'}, {'measure': 'miscarriage', 'timeFrame': 'pregnancy loss before 20 weeks of gestation, after a positive pregnancy test'}, {'measure': 'stimulation characteristics', 'timeFrame': 'from start of stimulation until embryo transfer', 'description': 'total dose of gonadotropins administered,'}, {'measure': 'cancellation rate', 'timeFrame': 'from start of stimulation until ET', 'description': 'when premature ovulation was evident by the loss of follicle(s) prior to oocyte recovery, and in cases where there were no oocytes retrieved or no embryos produced for transfer and in failed fertilization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ovarian stimulation', 'climiphene citrate', 'Gonadotropin-Releasing Hormone agonists/antagonists', 'Follicle Stimulating Hormone'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'The investigators will examine the balance between IVF success in terms of outcome parameters, using a mild ovarian stimulation protocol, opposing it to the conventional stimulation regimens in poor responders undergoing IVF.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* poor responders (age\\>40, previous POR, abnormal OR test)\n* indication for IVF\n* regular cycling patients\n* BMI 19-35\n\nExclusion Criteria:\n\n* contraindication for clomiphene citrate use or to GnRH agonists antagonists\n* BMI \\> 35'}, 'identificationModule': {'nctId': 'NCT01319708', 'briefTitle': 'Mild Versus Conventional Ovarian Stimulation for Poor Responders Undergoing In Vitro Fertilisation', 'organization': {'class': 'OTHER', 'fullName': 'National and Kapodistrian University of Athens'}, 'officialTitle': 'Mild Versus Conventional Ovarian Stimulation for Poor Responders Undergoing In Vitro Fertilisation', 'orgStudyIdInfo': {'id': '1234561'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mild ovarian stimulation', 'description': '100 mg CC by day 2 till 6, plus antagonist plus gonadotrophin 150-200IO until HCG triggering', 'interventionNames': ['Procedure: mild ovarian stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional ovarian stimulation', 'description': '300-450 IU of FSH starting by day 2 of menstrual cycle together with a fixed dose of GnRH antagonist starting by day 6 till egg recovery, or same doses using a GnRH agonist long protocol', 'interventionNames': ['Procedure: conventional ovarian stimulation']}], 'interventions': [{'name': 'mild ovarian stimulation', 'type': 'PROCEDURE', 'description': '100-150 mg of clomiphene citrate from day 2 till day 6 of the cycle and 150 mg of gonadotrophins as soon as 1 follicle is more than 14mm together with 1 fixed dose of GnRH antagonist until egg recovery', 'armGroupLabels': ['mild ovarian stimulation']}, {'name': 'conventional ovarian stimulation', 'type': 'PROCEDURE', 'description': '300-450 IU of FSH starting by day 2 of menstrual cycle together with a fixed dose of GnRH antagonist starting by day 6 till egg recovery, or same doses with GnRH agonist long protocol', 'armGroupLabels': ['conventional ovarian stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12462', 'city': 'Athens', 'state': 'Chaidari', 'country': 'Greece', 'facility': '3rd Department of Obstetrics & Gynecology, Assisted Reproduction Unit', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Director of the ARU', 'investigatorFullName': 'Siristatidis Charalampos, MD, PhD', 'investigatorAffiliation': 'National and Kapodistrian University of Athens'}}}}