Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT06759220
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-06
First Post:
2024-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hystrolaparoscopic Findings in Infertile Women with Previous Uterine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2028-09-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-30', 'studyFirstSubmitDate': '2024-12-30', 'studyFirstSubmitQcDate': '2024-12-30', 'lastUpdatePostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary (main): rate and pattern of abnormal laparoscopic and hysteroscopic findings in infertile women with previous uterine surgery', 'timeFrame': 'Baseline', 'description': 'Primary (main): rate and pattern of abnormal laparoscopic and hysteroscopic findings in infertile women with previous uterine surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hystrolaparoscopic Findings in Infertile Women with Previous Uterine Surgeries']}, 'referencesModule': {'references': [{'pmid': '20642082', 'type': 'BACKGROUND', 'citation': 'Ibekwe PC, Udensi AM, Imo AO. Hysterosalpingographic findings in patients with infertility in South eastern Nigeria. Niger J Med. 2010 Apr-Jun;19(2):165-7. doi: 10.4314/njm.v19i2.56510.'}, {'pmid': '21860133', 'type': 'BACKGROUND', 'citation': 'Bukar M, Mustapha Z, Takai UI, Tahir A. Hysterosalpingographic findings in infertile women: a seven year review. Niger J Clin Pract. 2011 Apr-Jun;14(2):168-70. doi: 10.4103/1119-3077.84008.'}, {'pmid': '16918185', 'type': 'BACKGROUND', 'citation': 'Bello TO. Tubal abnormalities on hysterosalpingography in primary and secondary infertility. West Afr J Med. 2006 Apr-Jun;25(2):130-3. doi: 10.4314/wajm.v25i2.28263.'}, {'pmid': '18446041', 'type': 'BACKGROUND', 'citation': 'Adesiyun AG, Ameh CA, Eka A. Hysterosalpingographic tubal abnormalities and HIV infection among black women with tubal infertility in sub-Saharan Africa. Gynecol Obstet Invest. 2008;66(2):119-22. doi: 10.1159/000128600. Epub 2008 Apr 29.'}]}, 'descriptionModule': {'briefSummary': '1. to determine the rate and pattern of abnormal laparoscopic finding among the infertile women with history of previous uterine surgery.\n2. To detemine the rate and pattern of abnormal hysteroscopic finding among infertile women with with history of previous uterine sergery\n3. to evaluate the value of doing combined laparoscopy and hysteroscopy in infertile women with with history of previous uterine surgery.\n4. To determine possible risk factors of pelvic adhesions detected during laparoscopy.\n5. To determine possible risk factors causing cs niche.', 'detailedDescription': "nfertility(1), which refers to the inability of a couple to conceive after one year of regular unprotected sexual intercourse, is the commonest indication for gynacological consultation. primary infertility - where someone who's never conceived a child in the past. secondary infertility(2) - where someone has had 1 or more pregnancies in the past, but is having difficulty conceiving again.there are many causes for infertility. (3)uterine causes as uterine fibroids or malformations.tubal factors as tuboperitoneal adhesions,unilateral or bilateral proximal occlusion unilateral or bilateral hydrosalpinx or pyosalpinx.Ovarian factors ovarian cyst,polycystic ovaries.pelvic causes as adhesions ,endometriosis and miscellaneous. laparoscopy can be used as the gold standard diagnostic tool which allows direct visualization of all pelvic organs. It also helps in detailed assessment of fallopian tubes. The advantage behind using laparoscopy is that the treatment of certain conditions such as tubal obstruction, endometriosis, and pelvic adhesions can be done at the same time during diagnosis. If needed, laparoscopic chromopertubation can also be done for tubal patency during the same sitting. (4)Hysteroscopy is the direct visualization of the uterine cavity using an endoscope. Uterine cavity evaluation is very much needed to do achieve total infertility workup. Uterine abnormalities are present among 10-15% of couples who seek treatment of infertility. For evaluation of endometrial factors,(5) hysteroscopy considered to be a gold standard. Diagnostic h hysteroscopy can detect uterine anomalies which remain undetected in USG and other routine investigations.\n\nMany studies reported the occurrence of pelvic adhesions following cesarean section with its related consequences.\n\npelvic adhesions may affect both reproductive system anatomy and function, causing various associated conditions. Pelvic adhesions may cause secondary infertility, which might be due to dyspareunia, disturbing tubo-ovarian relationship, or disturbing peristaltic movement of fallopian tube."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infertile women between age of 20to 35yr with previous uterine surgeries', 'genderDescription': 'Females', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All women between20 to 35 yrs old with secondary infertiliy for 2 years\n* Women with previous uterine surgery\n\nExclusion Criteria:\n\n* Female with major medical illness(Uncontrolled daibetes, cardiac diseases, uncontrolled thyroid disorders)\n* Abnormal semen parameter of the husband.'}, 'identificationModule': {'nctId': 'NCT06759220', 'briefTitle': 'Hystrolaparoscopic Findings in Infertile Women with Previous Uterine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Hystrolaparosciopic Findings in Infertile Women with Secondary Infertility', 'orgStudyIdInfo': {'id': 'Laparoscopy in infertility'}}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': "Women's health hospital Assiut University", 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Dalia Ali, Master', 'role': 'CONTACT', 'email': 'daliaheaven@gmail.com', 'phone': '01065206186'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dalia Ali Ramadan', 'investigatorFullName': 'Dalia Ali Ramadan', 'investigatorAffiliation': 'Assiut University'}}}}