Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT04338035
Status:
COMPLETED
Last Update Posted:
2020-11-18
First Post:
2020-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fertility in Untreated Rectosigmoid Endometriosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-16', 'studyFirstSubmitDate': '2020-04-05', 'studyFirstSubmitQcDate': '2020-04-05', 'lastUpdatePostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '4-9 weeks after conception', 'description': 'Ultrasonographic evidence of intrauterine gestational sac'}, {'measure': 'Live birth rate', 'timeFrame': '22 weeks after conception', 'description': 'Complete expulsion or extraction from a woman of a product of fertilization after 22 completed weeks of gestational age, which, after such separation, breathes or shows any other evidence of life'}], 'secondaryOutcomes': [{'measure': 'Number (%) of patients conceiving spontaneously/by Assisted Reproductive Technology', 'timeFrame': 'Immediately after diagnosis of clinical pregnancy', 'description': 'Modality of conception'}, {'measure': 'Number (%) of patients undergoing vaginal delivery/delivering by cesarean section', 'timeFrame': '22-42 weeks after conception', 'description': 'Modality of delivery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometriosis', 'Bowel Endometriosis', 'Endometriosis, Rectum', 'Endometriosis Colon']}, 'referencesModule': {'references': [{'pmid': '17572918', 'type': 'BACKGROUND', 'citation': 'Remorgida V, Ferrero S, Fulcheri E, Ragni N, Martin DC. Bowel endometriosis: presentation, diagnosis, and treatment. Obstet Gynecol Surv. 2007 Jul;62(7):461-70. doi: 10.1097/01.ogx.0000268688.55653.5c.'}]}, 'descriptionModule': {'briefSummary': 'Several studies investigated the reproductive outcomes after surgical treatment of colorectal endometriosis, mainly segmental colorectal resection. Little information is available on the spontaneous fertility of patients with bowel endometriosis. This study aims to evaluate the fertility of patients affected by rectosigmoid endometriosis who did not undergo previous surgical treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with rectosigmoid endometriosis not undergoing surgical treatment', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Desire of conception\n* Diagnosis of rectosigmoid endometriosis by transvaginal ultrasonography (TVS) and magnetic resonance imaging enema (MR-e)\n\nExclusion Criteria:\n\n* Previous surgery for endometriosis\n* Diagnosis of hydrosalpinx at imaging\n* Previous conception\n* Abnormal semen parameters of male partners'}, 'identificationModule': {'nctId': 'NCT04338035', 'briefTitle': 'Fertility in Untreated Rectosigmoid Endometriosis', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale Policlinico San Martino'}, 'officialTitle': 'Fertility in Patients With Untreated Rectosigmoid Endometriosis', 'orgStudyIdInfo': {'id': 'FERT-RECTOSIGM-ENDO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with rectosigmoid endometriosis', 'interventionNames': ['Behavioral: Expectant management']}], 'interventions': [{'name': 'Expectant management', 'type': 'BEHAVIORAL', 'description': 'Patients did not undergo surgical treatment for endometriosis and medical consultations were done every 6 months from the beginning of the attempts to conceive', 'armGroupLabels': ['Patients with rectosigmoid endometriosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16132', 'city': 'Genoa', 'country': 'Italy', 'facility': 'IRCCS Ospedale Policlinico San Martino', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale Policlinico San Martino', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fabio Barra', 'investigatorAffiliation': 'Ospedale Policlinico San Martino'}}}}