Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT00750451
Status:
COMPLETED
Last Update Posted:
2009-03-20
First Post:
2008-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Molecular Weight Heparin in Recurrent Implantation Failure
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': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'C400424', 'term': 'Crinone'}, {'id': 'D005782', 'term': 'Gels'}], 'ancestors': [{'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-19', 'studyFirstSubmitDate': '2008-09-09', 'studyFirstSubmitQcDate': '2008-09-09', 'lastUpdatePostDateStruct': {'date': '2009-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ongoing pregnancy beyond the 20th gestational week rate'}], 'secondaryOutcomes': [{'measure': 'Clinical pregnancy rate'}, {'measure': 'Embryo implantation rate'}]}, 'conditionsModule': {'keywords': ['fertilization in vitro', 'assisted reproduction', 'recurrent implantation failure', 'low molecular weight heparin', 'heparin', 'luteal phase'], 'conditions': ['Infertility', 'Fertilization in Vitro', 'Recurrent Implantation Failure']}, 'referencesModule': {'references': [{'pmid': '19357135', 'type': 'DERIVED', 'citation': 'Urman B, Ata B, Yakin K, Alatas C, Aksoy S, Mercan R, Balaban B. Luteal phase empirical low molecular weight heparin administration in patients with failed ICSI embryo transfer cycles: a randomized open-labeled pilot trial. Hum Reprod. 2009 Jul;24(7):1640-7. doi: 10.1093/humrep/dep086. Epub 2009 Apr 8.'}]}, 'descriptionModule': {'briefSummary': 'Recurrent implantation failure is the failure to achieve a pregnancy after multiple attempts with in vitro fertilization treatment. The reason is usually obscure. Many empirical treatments have been offered without substantial evaluation. Heparin is thought to play a role in the embryo implantation process beyond its anticoagulation effects. The proposed study aims to assess the effectiveness and safety of empirical administration of low molecular weight heparin in patients undergoing a new IVF treatment cycle after multiple failed attempts.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of at least two previously failed fresh embryo transfer cycles\n* All previously failed cycles to be performed in the American Hospital of Istanbul\n* Female age ≤ 38 years\n* Fresh ejaculate sperms to be used for ICSI\n* No hormonal, coagulation, or immunological disorders detected\n* Normal uterine cavity, as assessed by diagnostic office hysteroscopy or saline infusion sonography\n* Normal female and male peripheral karyotype'}, 'identificationModule': {'nctId': 'NCT00750451', 'briefTitle': 'Low Molecular Weight Heparin in Recurrent Implantation Failure', 'organization': {'class': 'OTHER', 'fullName': 'V.K.V. American Hospital, Istanbul'}, 'officialTitle': 'Empirical Low Molecular Weight Heparin Administration in the Luteal Phase in Patients With Recurrent Implantation Failures: a Randomized Open Labeled Trial', 'orgStudyIdInfo': {'id': 'AH-05/11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LMWH', 'description': 'Women in the LMWH arm are administered 1 mg/kg/day subcutaneously low molecular weight heparin after oocyte collection in addition to routine luteal phase support with vaginal progesterone', 'interventionNames': ['Drug: low molecular weight heparin (enoxaparine sodium)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Women in the control arm are administered routine luteal phase support without the addition of LMWH', 'interventionNames': ['Drug: crinone 8% gel']}], 'interventions': [{'name': 'low molecular weight heparin (enoxaparine sodium)', 'type': 'DRUG', 'description': '1 mg/kg/day subcutaneously in the luteal phase after IVF treatment', 'armGroupLabels': ['LMWH']}, {'name': 'crinone 8% gel', 'type': 'DRUG', 'description': 'routine luteal phase support with progesterone gel', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34365', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Assisted Reproduction Unit of the American Hospital of Istanbul', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Cumhur B Urman, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'American Hospital of Istanbul'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'V.K.V. American Hospital, Istanbul', 'class': 'OTHER'}}}}