Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-30 @ 6:36 PM
Study NCT ID:
NCT01319695
Status:
COMPLETED
Last Update Posted:
2021-03-17
First Post:
2011-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Corifollitropin Alfa Versus Recombinant Follicle Stimulating Hormone (FSH) in Ovarian Stimulation of Women 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C437186', 'term': 'follicle stimulating hormone, human, with HCG C-terminal peptide'}, {'id': 'D015292', 'term': 'Glycoprotein Hormones, alpha Subunit'}], 'ancestors': [{'id': 'D006063', 'term': 'Chorionic Gonadotropin'}, {'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D005640', 'term': 'Follicle Stimulating Hormone'}, {'id': 'D006065', 'term': 'Gonadotropins, Pituitary'}, {'id': 'D007986', 'term': 'Luteinizing Hormone'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D013972', 'term': 'Thyrotropin'}, {'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-15', 'studyFirstSubmitDate': '2011-03-08', 'studyFirstSubmitQcDate': '2011-03-21', 'lastUpdatePostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'no of oocytes (>2 between groups)', 'timeFrame': 'at egg recovery, through study completion, an average of 2 years'}], 'secondaryOutcomes': [{'measure': 'Clinical pregnancy rate cancellation rate miscarriage rate ectopic pregnancy rate', 'timeFrame': '3 weeks after embryo transfer', 'description': 'The presence of fetal heart at transvaginal ultrasound at 6+2 gestational weeks'}, {'measure': 'Ongoing pregnancy rate', 'timeFrame': '12 weeks after embryo transfer', 'description': 'The presence of fetal heart at ultrasound after 12 gestational weeks'}, {'measure': 'miscarriage rate', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'live birth rate', 'timeFrame': 'through study completion, an average of 2 years'}]}, 'conditionsModule': {'keywords': ['corifollitropin alfa', 'FSH ovarian stimulation', 'IVF'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '28508691', 'type': 'RESULT', 'citation': 'Siristatidis C, Dafopoulos K, Christoforidis N, Anifandis G, Pergialiotis V, Papantoniou N. Corifollitropin alfa compared with follitropin beta in GnRH-antagonist ovarian stimulation protocols in an unselected population undergoing IVF/ICSI. Gynecol Endocrinol. 2017 Dec;33(12):968-971. doi: 10.1080/09513590.2017.1323203. Epub 2017 May 16.'}]}, 'descriptionModule': {'briefSummary': 'The use of corifollitropin alfa is superior in terms of pregnancy outcome parameters as compared to recombinant follicle stimulating hormone (FSH) during ovarian stimulation protocols in women undergoing in vitro fertilisation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '36 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18-36 years old with a body weight of more than 60 kg up to 90 kg\n* BMI of 18-32 kg/m2\n* Menstrual cycle length of 23-35 days\n* An indication for controlled ovarian stimulation for IVF or ICSI\n\nExclusion Criteria:\n\n* history of an endocrine abnormality\n* abnormal outcome of blood biochemistry or hematology\n* abnormal cervical smear\n* chronic disease\n* uterine pathology that interfering with the COS treatment (e.g. fibroids ≥ 5 cm)'}, 'identificationModule': {'nctId': 'NCT01319695', 'briefTitle': 'Corifollitropin Alfa Versus Recombinant Follicle Stimulating Hormone (FSH) in Ovarian Stimulation of Women Undergoing in Vitro Fertilisation', 'organization': {'class': 'OTHER', 'fullName': 'National and Kapodistrian University of Athens'}, 'orgStudyIdInfo': {'id': '1234560'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'corifollitropin alfa', 'interventionNames': ['Drug: corifollitropin alfa']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'recombinant follicle stimulating hormone (FSH)', 'description': '150-300 IU of FSH for ovarian stimulation in women undergoing IVF', 'interventionNames': ['Drug: recombinant follicle stimulating hormone (FSH)']}], 'interventions': [{'name': 'corifollitropin alfa', 'type': 'DRUG', 'description': '100 microg for a group of women weighing \\<or=60 kg and 150 microg for a group of women weighing \\>60 kg', 'armGroupLabels': ['corifollitropin alfa']}, {'name': 'recombinant follicle stimulating hormone (FSH)', 'type': 'DRUG', 'description': '150-300 IU of the drug daily from day 2 of the menstrual cycle until more than 2 follicles are \\>18mm', 'armGroupLabels': ['recombinant follicle stimulating hormone (FSH)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12462', 'city': 'Athens', 'state': 'Chaidari', 'country': 'Greece', 'facility': '3rd Department of Obstetrics and Gynecology, Assisted Reproduction Unit', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '12642', 'city': 'Athens', 'state': 'Chaidari', 'country': 'Greece', 'facility': 'Attikon University Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We will be happy to share the data'}, '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'}}}}