Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT01040351
Status:
COMPLETED
Last Update Posted:
2011-08-29
First Post:
2009-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Ultrasound Guided Aspiration of Hydrosalpingeal Fluid and IVF-ET Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'umfrfouda@yahoo.com', 'phone': '+20123595106', 'title': 'Usama M.Fouda, M.D, PhD', 'organization': 'Cairo university'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Several patients refused to participate in the study'}}, 'adverseEventsModule': {'timeFrame': 'October 2006 to May 2010', 'eventGroups': [{'id': 'EG000', 'title': '1: Hydrosalpinx Needle Aspiration', 'description': 'Aspiration of hydrosalpingeal fluid prior to IVF-ET', 'otherNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2. no Aspiration', 'description': 'IVF-ET without any prior intervention', 'otherNumAtRisk': 53, 'otherNumAffected': 0, 'seriousNumAtRisk': 53, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ovarian hyperstimulation syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Flaring of pelvic infection and peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1: Hydrosalpinx Needle Aspiration', 'description': 'After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .'}, {'id': 'OG001', 'title': '2. no Aspiration', 'description': 'IVF-ET is done without prior aspiration of hydrosalpingeal fluid'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.02', 'ciLowerLimit': '1.13', 'ciUpperLimit': '8.0', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': '. The aggregate result of 6 studies reporting the pregnancy rate of patients with ultrasound visible hydrosalpinx revealed that clinical pregnancy rate among the patients with ultrasound-visible hydrosalpinges was 12.6%. We assumed that the aspiration of hydrosalpinx could restore clinical pregnancy rate to that expected for patients with tubal factor of infertility but without hydrosalpinges (about 36.5% in our hospital)'}], 'paramType': 'NUMBER', 'timeFrame': '5 weeks after embryo transfer', 'description': 'The Number of Participants Who Achieved Clinical Pregnancy( presence of intrauterine gestational sac detected by transvaginal ultrasound\n\n)in a transfer cycle', 'unitOfMeasure': 'participents', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients undergoing embryo transfer were included in final analysis'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle .', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1: Hydrosalpinx Needle Aspiration', 'description': 'After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .'}, {'id': 'OG001', 'title': '2. no Aspiration', 'description': 'IVF-ET is done without prior aspiration of hydrosalpingeal fluid'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 weeks after embryo transfer', 'description': 'The number of participants who Achieved Ongoing pregnancy (pregnancy for more than 18 weeks after embryo transfer) in a transfer cycle .', 'unitOfMeasure': 'participents', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who underwent embryo transfer were included in the final analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1: Hydrosalpinx Needle Aspiration', 'description': 'After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .'}, {'id': 'FG001', 'title': '2. no Aspiration', 'description': 'IVF-ET is done without prior aspiration of hydrosalpingeal fluid'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'October 2006', 'groupId': 'FG000', 'numSubjects': '55'}, {'comment': 'October 2006', 'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'May 2010', 'groupId': 'FG000', 'numSubjects': '54'}, {'comment': 'May 2010', 'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'poor ovarian response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This study was two arm prospective randomized controlled study including 110 fresh IVF- ETs from 110 patients , undertaken between October 2006 to May 2010 at the assisted conception unit of Ahmed Elgazzar hospital , Cairo , Egypt.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '1: Hydrosalpinx Needle Aspiration', 'description': 'After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .'}, {'id': 'BG001', 'title': '2. no Aspiration', 'description': 'IVF-ET is done without prior aspiration of hydrosalpingeal fluid'}, {'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': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', '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': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.16', 'spread': '3.6', 'groupId': 'BG000'}, {'value': '29.38', 'spread': '4.0', 'groupId': 'BG001'}, {'value': '28.77', 'spread': '3.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}, {'title': 'Male', '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': 'Egypt', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-29', 'studyFirstSubmitDate': '2009-12-28', 'resultsFirstSubmitDate': '2010-05-10', 'studyFirstSubmitQcDate': '2009-12-28', 'lastUpdatePostDateStruct': {'date': '2011-08-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-29', 'studyFirstPostDateStruct': {'date': '2009-12-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle', 'timeFrame': '5 weeks after embryo transfer', 'description': 'The Number of Participants Who Achieved Clinical Pregnancy( presence of intrauterine gestational sac detected by transvaginal ultrasound\n\n)in a transfer cycle'}], 'secondaryOutcomes': [{'measure': 'The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle .', 'timeFrame': '18 weeks after embryo transfer', 'description': 'The number of participants who Achieved Ongoing pregnancy (pregnancy for more than 18 weeks after embryo transfer) in a transfer cycle .'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Infertility', 'Hydrosalpinx', 'IVF-ET'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '18343810', 'type': 'BACKGROUND', 'citation': 'Hammadieh N, Coomarasamy A, Ola B, Papaioannou S, Afnan M, Sharif K. Ultrasound-guided hydrosalpinx aspiration during oocyte collection improves pregnancy outcome in IVF: a randomized controlled trial. Hum Reprod. 2008 May;23(5):1113-7. doi: 10.1093/humrep/den071. Epub 2008 Mar 13.'}, {'pmid': '20672903', 'type': 'DERIVED', 'citation': 'Fouda UM, Sayed AM. Effect of ultrasound-guided aspiration of hydrosalpingeal fluid during oocyte retrieval on the outcomes of in vitro fertilisation-embryo transfer: a randomised controlled trial (NCT01040351). Gynecol Endocrinol. 2011 Aug;27(8):562-7. doi: 10.3109/09513590.2010.507290. Epub 2010 Jul 30.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine whether the ultrasound guided aspiration of hydrosalpingeal fluid at the time of oocyte retrieval can improve the outcomes of IVF-ET .', 'detailedDescription': 'A Cochrane review of prospective randomized trials of laparoscopic salpingectomy confirmed the beneficial effect of laparoscopic salpingectomy on IVF ET outcomes in patients with hydrosalpinges. Surgery is not usually safe especially in patients with extensive adhesions, morbid obesity and previous multiple laparotomies. Other less invasive options for patients with hydrosalpinges as ultrasound guided aspiration of hydrosalpingeal fluid, antibiotics and hysteroscopic occlusion of fallopian tube were studied in order to find an alternative to salpingectomy. Although these methods are simple and getting popular,current data are inadequate to recommend these treatment options instead of salpingectomy. The aim of this study is to determine whether the ultrasound guided aspiration of hydrosalpingeal fluid at the time of oocyte retrieval can improve the outcomes of IVF-ET .'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '37 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with unilateral or bilateral hydrosalpinges visible by ultrasound\n* Age between 18 - 37 years\n* Period of infertility \\> 1 year\n* Body mass index between 19-29\n* Normal basal luteinizing hormone (LH), follicle stimulating hormone (FSH) and prolactin concentrations\n* Normal recent semen analysis (according to World Health Organization criteria)\n\nExclusion Criteria:\n\n* Uterine fibroid requiring surgical removal\n* Endometriosis\n* Male factor of infertility requiring ICSI\n* Previous IVF cycles\n* History of recurrent miscarriage\n* Endocrinologic disorders\n* Presence of systemic disease contraindicating pregnancy'}, 'identificationModule': {'nctId': 'NCT01040351', 'briefTitle': 'Ultrasound Guided Aspiration of Hydrosalpingeal Fluid and IVF-ET Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Ultrasound Guided Aspiration of Hydrosalpingeal Fluid at the Time of Oocyte Retrieval on the Outcomes of IVF-ET, a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'hydrosalpinx1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1: Hydrosalpinx needle aspiration', 'description': 'After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .', 'interventionNames': ['Procedure: ultrasound guided aspiration of hydrosalpingeal fluid']}, {'type': 'NO_INTERVENTION', 'label': '2. no aspiration', 'description': 'IVF-ET is done without prior aspiration of hydrosalpingeal fluid'}], 'interventions': [{'name': 'ultrasound guided aspiration of hydrosalpingeal fluid', 'type': 'PROCEDURE', 'otherNames': ['ultrasound guided Hydrosalpinx needle aspiration'], 'description': 'Under deep sedation, the retrieval of oocytes is done and then an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely . If there are bilateral hydrosalpinges, the process is repeated on the opposite side.', 'armGroupLabels': ['1: Hydrosalpinx needle aspiration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12111', 'city': 'Giza', 'state': '35 Eleshreen Saint King Faisal.', 'country': 'Egypt', 'facility': 'Ahmed Elgazzar hospital , Assisted conception unit', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Usama M Fouda, M.D, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Lecturer of obstetrics and Gynecology , Faculty of medicine ,Cairo university.'}, {'name': 'Ahmed M sayed, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistant professor of obstetrics and Gynecology , Faculty of medicine ,Cairo university.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ahmed Elgazzar Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Usama Fouda , MD, PhD', 'oldOrganization': 'Cairo university.'}}}}