Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-02-24 @ 10:52 AM
Study NCT ID:
NCT03854292
Status:
COMPLETED
Last Update Posted:
2019-07-15
First Post:
2019-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydrosalpinx Management Before Intracytoplasmic Sperm Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-12', 'studyFirstSubmitDate': '2019-02-23', 'studyFirstSubmitQcDate': '2019-02-23', 'lastUpdatePostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proximal tubal occlusion Success rate .', 'timeFrame': '15 months', 'description': 'proximal tubal occlusion Success rate among two groups detected by Hysterosalpingogram.'}], 'secondaryOutcomes': [{'measure': 'Pregnancy rate among the two groups.', 'timeFrame': '15 months', 'description': 'Chemical Pregnancy rate among the two groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hydrosalpinx']}, 'referencesModule': {'references': [{'pmid': '7929732', 'type': 'BACKGROUND', 'citation': 'Strandell A, Waldenstrom U, Nilsson L, Hamberger L. Hydrosalpinx reduces in-vitro fertilization/embryo transfer pregnancy rates. Hum Reprod. 1994 May;9(5):861-3. doi: 10.1093/oxfordjournals.humrep.a138606.'}, {'pmid': '10548619', 'type': 'BACKGROUND', 'citation': 'Strandell A, Lindhard A, Waldenstrom U, Thorburn J, Janson PO, Hamberger L. Hydrosalpinx and IVF outcome: a prospective, randomized multicentre trial in Scandinavia on salpingectomy prior to IVF. Hum Reprod. 1999 Nov;14(11):2762-9. doi: 10.1093/humrep/14.11.2762.'}, {'pmid': '10875845', 'type': 'BACKGROUND', 'citation': 'Puttemans P, Campo R, Gordts S, Brosens I. Hydrosalpinx and ART: hydrosalpinx--functional surgery or salpingectomy? Hum Reprod. 2000 Jul;15(7):1427-30. doi: 10.1093/humrep/15.7.1427.'}, {'pmid': '19147140', 'type': 'BACKGROUND', 'citation': 'Mijatovic V, Veersema S, Emanuel MH, Schats R, Hompes PG. Essure hysteroscopic tubal occlusion device for the treatment of hydrosalpinx prior to in vitro fertilization-embryo transfer in patients with a contraindication for laparoscopy. Fertil Steril. 2010 Mar 1;93(4):1338-42. doi: 10.1016/j.fertnstert.2008.11.022. Epub 2009 Jan 14.'}, {'pmid': '16412752', 'type': 'BACKGROUND', 'citation': 'Savaris RF, Pedrini JL, Flores R, Fabris G, Zettler CG. Expression of alpha 1 and beta 3 integrins subunits in the endometrium of patients with tubal phimosis or hydrosalpinx. Fertil Steril. 2006 Jan;85(1):188-92. doi: 10.1016/j.fertnstert.2005.06.039.'}, {'pmid': '15016787', 'type': 'BACKGROUND', 'citation': 'Hammadieh N, Afnan M, Evans J, Sharif K, Amso N, Olufowobi O. A postal survey of hydrosalpinx management prior to IVF in the United Kingdom. Hum Reprod. 2004 Apr;19(4):1009-12. doi: 10.1093/humrep/deh133. Epub 2004 Mar 11.'}, {'pmid': '17069813', 'type': 'BACKGROUND', 'citation': 'Kontoravdis A, Makrakis E, Pantos K, Botsis D, Deligeoroglou E, Creatsas G. Proximal tubal occlusion and salpingectomy result in similar improvement in in vitro fertilization outcome in patients with hydrosalpinx. Fertil Steril. 2006 Dec;86(6):1642-9. doi: 10.1016/j.fertnstert.2006.05.032. Epub 2006 Oct 25.'}, {'pmid': '26140948', 'type': 'BACKGROUND', 'citation': 'El-Mazny A, Abou-Salem N, Hammam M, Saber W. Hysteroscopic tubal electrocoagulation versus laparoscopic tubal ligation for patients with hydrosalpinges undergoing in vitro fertilization. Int J Gynaecol Obstet. 2015 Sep;130(3):250-2. doi: 10.1016/j.ijgo.2015.04.039. Epub 2015 Jul 2.'}, {'pmid': '22442504', 'type': 'BACKGROUND', 'citation': 'Parihar M, Mirge A, Hasabe R. Hydrosalpinx functional surgery or salpingectomy? The importance of hydrosalpinx fluid in assisted reproductive technologies. J Gynecol Endosc Surg. 2009 Jan;1(1):12-6. doi: 10.4103/0974-1216.51903.'}, {'pmid': '10942471', 'type': 'BACKGROUND', 'citation': 'Stadtmauer LA, Riehl RM, Toma SK, Talbert LM. Cauterization of hydrosalpinges before in vitro fertilization is an effective surgical treatment associated with improved pregnancy rates. Am J Obstet Gynecol. 2000 Aug;183(2):367-71. doi: 10.1067/mob.2000.107671.'}]}, 'descriptionModule': {'briefSummary': 'ICSI pregnancy outcomes following hysteroscopic tubal electrocoagulation versus laparoscopic tubal disconnection for patients with hydrosalpinges', 'detailedDescription': 'Tubal factor of infertility resulting from various forms of tuboperitoneal damage remains an extremely common cause of female infertility, accounting for more than 35% of all cases of female infertility. Probably the most severe form of tubal pathology is hydrosalpinx. Hydrosalpinx is a Greek word that means a Fallopian tube filled with water or fluid. Patients with hydrosalpinges have been identified as a subgroup with significantly lower implantation and pregnancy rates than patients with other tubal pathologies. An increased risk for early pregnancy loss and increased risk for ectopic pregnancies was reported, and many studies confirmed that the presence of hydrosalpinx significantly impairs in vitro fertilization (IVF) outcome as well.\n\nPatients with a hydrosalpinx have been found to have significantly poorer outcomes of IVF than do patients with tubal factor infertility but no hydrosalpinx .\n\nHydrosalpinges in infertile women reduce the success of IVF by 50 % .\n\nThe harmful effect of a hydrosalpinx on pregnancy rates after IVF has been attributed to mechanical washout of the transferred embryos by tubal-uterine reflux of the hydrosalpinx fluid .\n\nAdditionally, a hydrosalpinx might disturb endometrial receptivity: integrins, the best endometrial markers, show decreased expression in cases of hydrosalpinx .\n\nAltered endometrial blood flow has also been proposed as a possible factor causing decreased rates of implantation.\n\nAny surgical interventions that disrupt tubal-uterine communication in affected tubes might improve pregnancy rates .\n\nLaparoscopic salpingectomy was the most popular treatment option offered by the clinicians, followed by open salpingectomy, salpingostomy, proximal tubal occlusion and transvaginal ultrasonographic guided hydrosalpinx aspiration either before or during oocyte retrieval.The latest treatment option introduced was proximal occlusion of the hydrosalpinx by hysteroscopic placement of microinserts. Clinicians would still perform open salpingectomy. The possible explanation for this could be the lack of training in endoscopic surgery and/or that patients with tubal disease may have significant pelvic adhesions necessitating open surgery.\n\nLaparoscopic salpingectomy or tubal ligation has been shown to improve IVF outcomes for patients with a hydrosalpinx.\n\nHowever, this procedure has many drawbacks, including its invasiveness, the possibility of surgical injury (e.g. visceral injury, vascular damage, or unintended laparotomy), the potential risks from general anesthesia, and technical difficulty if there are pelvic adhesions .\n\nThe proximal occlusion of a hydrosalpinx by hysteroscopy might offer a feasible therapeutic alternative when laparoscopy is technically difficult or contraindicated,with the advantage of hysteroscopic procedures of faster recovery, less hospitalization and rapid return to work, and in the future it might be done in the outpatient clinic as an office procedure.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '50 patients who have unilateral or bilateral hydrosalpinges identified on hysterosalpingography and vaginal ultrasonography, and who are undergoing IVF.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 20 to 35 years\n* Primary or secondary infertility.\n* Diagnosis of hydrosalpinx; diagnosed by HSG and TV U/S.\n* Necessity of an IVF procedure.\n\nExclusion Criteria:\n\n* Patients with uterine factor infertility.\n* Medical or surgical conditions contraindicating pregnancy.\n* Poor responders according to reference criteria.\n* Cases of polycystic ovary disease.'}, 'identificationModule': {'nctId': 'NCT03854292', 'briefTitle': 'Hydrosalpinx Management Before Intracytoplasmic Sperm Injection', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'ICSI Pregnancy Outcomes Following Hysteroscopic Tubal Electrocoagulation Versus Laparoscopic Tubal Disconnection for Patients With Hydrosalpinges', 'orgStudyIdInfo': {'id': 'tubal disconnection'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hysteroscopic tubal electrocoagulation', 'description': 'Unilateral or bilateral electrocoagulation of the cornual end of the tube and the surrounding part of the uterine horn was performed using a hysteroscopic electrocoagulating roller ball', 'interventionNames': ['Procedure: Hysteroscopic tubal electrocoagulation']}, {'label': 'Laparoscopic tubal disconnection', 'description': 'Coagulation of the mid isthmus region of the affected Fallopian tube, with the bipolar forceps. using direct current that was no greater than 25 Watts.', 'interventionNames': ['Procedure: Hysteroscopic tubal electrocoagulation']}], 'interventions': [{'name': 'Hysteroscopic tubal electrocoagulation', 'type': 'PROCEDURE', 'description': 'Unilateral or bilateral electrocoagulation of the cornual end of the tube and the surrounding part of the uterine horn was performed using a hysteroscopicelectrocoagulating roller ball.', 'armGroupLabels': ['Hysteroscopic tubal electrocoagulation', 'Laparoscopic tubal disconnection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marwa Mohamed Abdalla', 'investigatorAffiliation': 'Cairo University'}}}}