Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-01-04 @ 3:28 AM
Study NCT ID:
NCT02861105
Status:
COMPLETED
Last Update Posted:
2016-08-12
First Post:
2016-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of LMWH on ICSI in Patients With Unexplained Infertility and Negative Immunological Markers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D017984', 'term': 'Enoxaparin'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 716}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-11', 'studyFirstSubmitDate': '2016-08-05', 'studyFirstSubmitQcDate': '2016-08-05', 'lastUpdatePostDateStruct': {'date': '2016-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live birth Rate', 'timeFrame': 'at delivery'}], 'secondaryOutcomes': [{'measure': 'Clinical Pregnancy Rate', 'timeFrame': 'at 7 weeks of gestation'}, {'measure': 'Biochemical Pregnancy Rate', 'timeFrame': '14 days after embryo transfer'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Unexplained Infertility']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of LMWH treatment in women with unexplained infertility and negative immunological markers undergoing ICSI.', 'detailedDescription': 'Inclusion criteria:\n\n1. patients undergoing 1st trial ICSI\n2. unexplained infertility\n3. negative immunological markers including ACL abs, LAC, ANA, ATA, AnitdsDNA\n\nExclusion criteria:\n\n1. previous IVF/ICSI\n2. Any cause of infertility\n3. Suspected and/or unexpected poor response during ovulation induction\n4. positive immunological markers\n5. Age \\> 40 years.\n\nAll participants will undergo IVF/ICSI cycle using the Long luteal phase protocol. the dose of gonadotropins will be calculated according to patient age and BMI. All patients will have 2-3 embryos transferred at D5 according to their age. the primary outcome will be LBR. secondary outcomes will include biochemical pregnancy rate and clinical pregnancy rate.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '38 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age less than 38 years\n* at least 12 months of infertility\n* women with unexplained infertility\n\nExclusion Criteria:\n\n* age more than or equals 38 years\n* serum AMH level less than or equals 1 ng/ml\n* patients of anticoagulant therapy\n* immune-compromised patients\n* patients with contraindications to low molecular weight heparin\n* positive immunological markers\n* patients with other than unexplained infertility\n* male factor infertility\n* refusal of participation\n* patients with unexpected poor or over response during induction of ovulation'}, 'identificationModule': {'nctId': 'NCT02861105', 'briefTitle': 'The Effect of LMWH on ICSI in Patients With Unexplained Infertility and Negative Immunological Markers', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Effect of LMWH on ICSI Outcome in Patients With Unexplained Infertility and Negative Immunological Markers; a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ASU-OG-333'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LMWH supplementation', 'description': '40 mg of enoxaparin injected subcutaneously every 24 hours starting the day of ovum pick-up to the documentation of fetal life by ultrasound at 7 weeks of gestation', 'interventionNames': ['Drug: LMWH']}, {'type': 'PLACEBO_COMPARATOR', 'label': '0.9% saline solution', 'description': '0.9% saline injected subcutaneously every 24 hours starting the day of ovum pick-up to the documentation of fetal life by ultrasound at 7 weeks of gestation', 'interventionNames': ['Other: 0.9% saline solution']}], 'interventions': [{'name': 'LMWH', 'type': 'DRUG', 'otherNames': ['Clexane', 'Enoxaparin'], 'description': 'LMWH will be given on daily basis subcutaneously every 24 hours starting one day after ovum pick up till documentation of fetal life by ultrasound at 7 weeks.', 'armGroupLabels': ['LMWH supplementation']}, {'name': '0.9% saline solution', 'type': 'OTHER', 'otherNames': ['0.9% sodium chloride solution'], 'description': '0.9% saline solution will be given subcutaneously every 24 hours starting one day after ovum pick up till documentation of fetal life by ultrasound at 7 weeks.', 'armGroupLabels': ['0.9% saline solution']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mostafa F Gomaa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mostafa Fouad Gomaa', 'investigatorAffiliation': 'Ain Shams University'}}}}