Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-01 @ 10:24 PM
Study NCT ID:
NCT05560295
Status:
COMPLETED
Last Update Posted:
2022-09-29
First Post:
2022-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hysteroscopic Surgery; Retrospective Cross-sectional Study of Reproductive Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-26', 'studyFirstSubmitDate': '2022-09-26', 'studyFirstSubmitQcDate': '2022-09-26', 'lastUpdatePostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pregnancy rate', 'timeFrame': '6 months', 'description': 'spontaneous'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hysteroscopic Metroplasty and Myomectomy']}, 'referencesModule': {'references': [{'pmid': '37644542', 'type': 'DERIVED', 'citation': 'Al-Husban N, Odeh O, AlRamahi M, Qadri S, Al-Husban H. Fertility-enhancing hysteroscopic surgery; multi-center retrospective cohort study of reproductive outcome. BMC Womens Health. 2023 Aug 29;23(1):459. doi: 10.1186/s12905-023-02562-2.'}]}, 'descriptionModule': {'briefSummary': 'study of the effect of hysteroscopic sptoplast and hysteroscopic myomectomy on reproductive performance of patients with infertility and /or miscarriages', 'detailedDescription': 'Retrospective study and analysis of the reproductive outcome in patients who underwent hysteroscopic surgery for infertility at Jordan university hospital and Al-Noor fertility centre in Amman, Jordan in the period September 2016-october 2021. Patients were followed up for a minimum of 6 months after surgery. Resection of uterine septum or submucosal fibroids were included. Data was obtained from the electronic and paper-based clinical files for patients who were operated upon at these hospitals. Patients who missed follow up after the operation will be contacted by phone or invite them for a clinic review to know of their fertility status and pregnancy outcome.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'female population with infertility or recurrent miscarriages who have uterine septum or fibroids', 'genderDescription': 'infertility patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* those with primary or secondary infertility of more than 1 year with normal seminal fluid analysis, normal female hormonal profile, patent fallopian tubes bilaterally (as confirmed by hysterosalpingography HSG), normal thyroid function, no previous uterine surgery and no medical diseases.\n* Cases with recurrent miscarriages were those with 2 or more first or second trimester miscarriages of an apparently normal singleton fetus with no hormonal, endocrine or maternal or paternal karyotype abnormalities and with no previous history of term pregnancy(s).\n\nExclusion Criteria:\n\n* All patients who were operated upon outside the context of infertility (heavy bleeding…etc), patients with combined (maternal and paternal) infertility factors,\n* Patients with history of any number of term pregnancy,\n* Previous uterine surgery,\n* Patients with medical diseases,\n* Those with abnormal female hormonal profile,\n* Those with other potential factors for infertility including endometriosis\n* Patients with incomplete or missing data and could not be contacted.\n* Patients who had myomectomy or septal resection done using bipolar hysteroscopy'}, 'identificationModule': {'nctId': 'NCT05560295', 'briefTitle': 'Hysteroscopic Surgery; Retrospective Cross-sectional Study of Reproductive Outcome', 'organization': {'class': 'OTHER', 'fullName': 'University of Jordan'}, 'officialTitle': 'Fertility-enhancing Hysteroscopic Surgery; Multi-center Retrospective Cross-sectional Study of Reproductive Outcome', 'orgStudyIdInfo': {'id': 'Hysteroscopic surgery'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Naser Al-Husban', 'type': 'PROCEDURE', 'description': 'uterine surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jordan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Naser Al-Husban', 'investigatorAffiliation': 'University of Jordan'}}}}