Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT01202656
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2010-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF (in Vitro Fertilization)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dbarad@theCHR.com', 'phone': '212 994-4400', 'title': 'Dr. David Barad', 'organization': 'Center for Human Reproduction'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study results are applicable only to women undergoing routine IVF. Most of the women in this trial had normal endometrial thickness at randomization.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'G-CSF', 'description': 'G-CSF (Granulocyte colony stimulating factor)\n\nG-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation', 'otherNumAtRisk': 81, 'otherNumAffected': 0, 'seriousNumAtRisk': 81, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Saline', 'description': 'Normal Saline\n\nSaline administered by trans-cervical infusion one time on day of hCG trigger for ovulation', 'otherNumAtRisk': 80, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Embryo Implantation and Clinical Pregnancy Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'Embryos Transferred', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'G-CSF', 'description': 'G-CSF (Granulocyte colony stimulating factor)\n\nG-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Normal Saline\n\nSaline administered by trans-cervical infusion one time on day of hCG trigger for ovulation'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.72', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '26 to 30 days after embryo transfer', 'description': 'Implantation rate: The number of gestational sacs noted in the endometrial cavity 26 to 30 days after embryo transfer divided by the number of embryos transferred\n\nClinical pregnancy:\n\nGestational sac with evidence of a viable pregnancy at least 28 days after embryo transfer', 'unitOfMeasure': 'Gestational sacs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Embryos Transferred', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Presuming an implantation rate of 10% and anticipating a 10% increase to 20% with treatment, about 200 embryos transferred in each study arm would be needed for 80% power and alpha of 0.05.'}, {'type': 'SECONDARY', 'title': 'Live Birth Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'G-CSF', 'description': 'G-CSF (Granulocyte colony stimulating factor)\n\nG-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Normal Saline\n\nSaline administered by trans-cervical infusion one time on day of hCG trigger for ovulation'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within nine months of embryo transfer', 'description': 'Live birth rates among normal infertile couples undergoing IVF', 'unitOfMeasure': 'Live Birth', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'G-CSF Then Saline', 'description': 'G-CSF (Granulocyte colony stimulating factor)\n\nG-CSF 300 units administered by trans-cervical infusion one time on day of human chorionic gonadotropin(hCG) trigger for Ovulation'}, {'id': 'FG001', 'title': 'Saline Then G-CSF', 'description': 'Normal Saline\n\nSaline administered by trans-cervical infusion one time on day of hCG trigger for ovulation'}], 'periods': [{'title': 'Cycle 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Results reported In Barad et al 2014 are combined from both G-CSF studies', 'groupId': 'FG000', 'numSubjects': '67'}, {'comment': 'Results reported In Barad et al 2014 are combined from both G-CSF studies', 'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'CrossoverCycle', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '16 ongoing pregnancies were not eligible for crossover, others chose to not have another IVF cycle', 'groupId': 'FG000', 'numSubjects': '18'}, {'comment': '14 ongoing pregnancies were not eligible for crossover, others chose to not have another IVF cycle', 'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'All patients presenting for embryos transfer between October 3, 2010, and January 1, 2013, were offered participation in the trial. A total of 419 eligible patients were offered participation: Only 129 patients consented to participate in this study,(12 addtional patient participated in the thin endometrium study) and 278 declined', 'preAssignmentDetails': "The principal reasons for refusal to participate were ''lack of interest'' and technical difficulties in presenting in timely fashion for the treatment to the center. Women with renal disease, sickle cell disease, or a history of malignancy were considered ineligible. No consenting patient was excluded from participation for medical reasons."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'G-CSF Then Saline', 'description': 'G-CSF (Granulocyte colony stimulating factor)\n\nG-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation\n\nthen\n\nNormal Saline\n\nSaline administered by trans-cervical infusion one time on day of hCG trigger for ovulation'}, {'id': 'BG001', 'title': 'Saline Then G-CSF', 'description': 'Normal Saline\n\nSaline administered by trans-cervical infusion one time on day of hCG trigger for ovulation\n\nthen\n\nG-CSF (Granulocyte colony stimulating factor)\n\nG-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'AntiMulerian Hormone (AMH)', 'classes': [{'categories': [{'measurements': [{'value': '2.07', 'spread': '2.17', 'groupId': 'BG000'}, {'value': '1.99', 'spread': '2.38', 'groupId': 'BG001'}, {'value': '2.03', 'spread': '2.26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-24', 'studyFirstSubmitDate': '2010-09-14', 'resultsFirstSubmitDate': '2014-05-18', 'studyFirstSubmitQcDate': '2010-09-14', 'lastUpdatePostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-24', 'studyFirstPostDateStruct': {'date': '2010-09-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Embryo Implantation and Clinical Pregnancy Rates', 'timeFrame': '26 to 30 days after embryo transfer', 'description': 'Implantation rate: The number of gestational sacs noted in the endometrial cavity 26 to 30 days after embryo transfer divided by the number of embryos transferred\n\nClinical pregnancy:\n\nGestational sac with evidence of a viable pregnancy at least 28 days after embryo transfer'}], 'secondaryOutcomes': [{'measure': 'Live Birth Rates', 'timeFrame': 'Within nine months of embryo transfer', 'description': 'Live birth rates among normal infertile couples undergoing IVF'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fertility Agents, Female', 'In vitro fertilization'], 'conditions': ['Infertility, Female']}, 'referencesModule': {'references': [{'pmid': '24424357', 'type': 'RESULT', 'citation': 'Barad DH, Yu Y, Kushnir VA, Shohat-Tal A, Lazzaroni E, Lee HJ, Gleicher N. A randomized clinical trial of endometrial perfusion with granulocyte colony-stimulating factor in in vitro fertilization cycles: impact on endometrial thickness and clinical pregnancy rates. Fertil Steril. 2014 Mar;101(3):710-5. doi: 10.1016/j.fertnstert.2013.12.016. Epub 2014 Jan 11.'}]}, 'descriptionModule': {'briefSummary': 'This a trial designed to test whether granulocyte colony stimulating factor (G-CSF, Neupogen) can increase the rate of embryo implantation following IVF and embryo transfer. Preliminary data at the Center for Human Reproduction(CHR) and elsewhere suggest that intrauterine infusion of G-CSF can improve endometrial development and can increase implantation rates of embryos.', 'detailedDescription': 'Objective: To investigate the effect of treatment with CSF on pregnancy rates in routine in vitro fertilization (IVF).\n\nDesign: Double blinded crossover randomized controlled clinical trial\n\nSetting: Academically affiliated private infertility centers\n\nSubjects: Normal female IVF patients 18-38 years old, and above age 38 years, who are willing to be randomized to treatment.\n\nInterventions: Subjects receive transvaginally, utilizing an insemination catheter, a slow uterine lavage with G-CSF (Neupogen), 300ug (in 1 ml); controls receive saline. Patients who do not conceive will, after one month washout time, continue treatment in the opposite study arm.\n\nMain Outcome Measures: Implantation rate(IR) and pregnancy rates.\n\nSecond Outcome Measures: Live birth rates and miscarriage rates.\n\nStatistical and Power considerations: Analysis will be by regression with IR as dependent and treatment as independent. Results will be adjusted by age and indices of ovarian reserve, such as antiMulerian Hormone (AMH). Presuming an implantation rate of 10% and anticipating a 10% increase to 20% with treatment, 120 women, producing about 200 embryos in each study arm, will have to be recruited for 80% power and alpha of 0.05.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women already enrolled in an IVF cycle at one of the participating institutions\n\nExclusion Criteria:\n\n* Sickle Cell disease\n* Renal insufficiency\n* Upper respiratory infection or Pneumonia\n* Chronic Neutropenia\n* Known Past or present malignancy'}, 'identificationModule': {'nctId': 'NCT01202656', 'briefTitle': 'Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF (in Vitro Fertilization)', 'organization': {'class': 'OTHER', 'fullName': 'Center for Human Reproduction'}, 'officialTitle': 'G-CSF(Granulocyte Colony Stimulating Factor) and Embryo Implantation and Pregnancy Following IVF (in Vitro Fertilization)', 'orgStudyIdInfo': {'id': '09012010-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'G-CSF then Saline', 'description': 'G-CSF (Granulocyte colony stimulating factor)', 'interventionNames': ['Drug: G-CSF', 'Drug: Saline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline then G-CSF', 'description': 'Normal Saline', 'interventionNames': ['Drug: G-CSF', 'Drug: Saline']}], 'interventions': [{'name': 'G-CSF', 'type': 'DRUG', 'otherNames': ['Neupogen (Filgrastim)'], 'description': 'One infusion of G-CSF 300 units administered by intrauterine infusion', 'armGroupLabels': ['G-CSF then Saline', 'Saline then G-CSF']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['Normal Saline', '0.91% w/v of NaCl, about 300 mOsm/L'], 'description': 'intrauterine saline infusion 1 cc', 'armGroupLabels': ['G-CSF then Saline', 'Saline then G-CSF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Center for Human Reproduction', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'David H Barad, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Human Reproduction'}, {'name': 'Norbert Gleicher, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Center for Human Reproduction'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for Human Reproduction', 'class': 'OTHER'}, 'collaborators': [{'name': 'Foundation for Reproductive Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Clinical Research', 'investigatorFullName': 'David H. Barad', 'investigatorAffiliation': 'Center for Human Reproduction'}}}}