Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2026-01-02 @ 6:45 PM
Study NCT ID:
NCT03173404
Status:
COMPLETED
Last Update Posted:
2017-06-01
First Post:
2017-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Benefits of Hysteroscopy Prior to Performing a Cycle of in Vitro Fertilization/Intracytoplasmic Sperm Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015907', 'term': 'Hysteroscopy'}], 'ancestors': [{'id': 'D003944', 'term': 'Diagnostic Techniques, Obstetrical and Gynecological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized open-label clinical trial. Women scheduled for their first or second IVF/ICSI cycle and with no abnormality detected in transvaginal ultrasound examination, were randomized to two groups.\n\nIn the first group (group I): 31 patients underwent hysteroscopy examination before IVF cycle.\n\nThe second group (group II): 37 patients underwent direct cycle without previous hysteroscopy.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-30', 'studyFirstSubmitDate': '2017-05-30', 'studyFirstSubmitQcDate': '2017-05-30', 'lastUpdatePostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of biochemical, clinical, on-going pregnancy and livebirth of IVF treatment', 'timeFrame': '12 months', 'description': 'Percentage of biochemical, clinical, on-going pregnancy and livebirth of IVF treatment comparing both groups.'}], 'secondaryOutcomes': [{'measure': 'Percentage of endocervical canal and uterine cavity pathology and the impact of treatment of these pathologies.', 'timeFrame': '12 months', 'description': 'Percentage of endocervical canal and uterine cavity pathology and the impact of treatment of these pathologies in the rate of pregnancy and livebirth.'}, {'measure': 'Rate of hysteroscopy tolerance', 'timeFrame': '1 month.', 'description': 'The tolerance of the procedure was evaluate in the patients randomized to the group I of the study.'}, {'measure': 'Hysteroscopy complication rate.', 'timeFrame': '2 months', 'description': 'We evaluate the complication of the hysteroscopy during and after the procedure. Includes blooding, infections, uterine perforation, etc.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sterility']}, 'descriptionModule': {'briefSummary': 'This is a prospective randomized open-label trial. Women scheduled for their first or second in-vitro fertilization/intracytoplasmatic Sperm Injection (IVF/ICSI) cycle and with no abnormality detected in transvaginal ultrasound examination, were randomized to two groups. In the first group (group I) 31 patients underwent hysteroscopy examination before IVF cycle while in the second group (group II) 37 patients underwent direct cycle without previous hysteroscopy', 'detailedDescription': 'This is a prospective randomized open-label trial. Women scheduled for their first or second IVF/ICSI cycle and with no abnormality detected in transvaginal ultrasound examination, were randomized to two groups. In the first group (group I) 31 patients underwent hysteroscopy examination before IVF cycle while in the second group (group II) 37 patients underwent direct cycle without previous hysteroscopy. Then IVF cycle was performed with habitual protocol. Beta Corionic Gonatropic hormone (BhCG) test two weeks after embryo transfer was done. If test was positive, patients were followed up for detection pregnancy by transvaginal ultrasound two weeks later. Another transvaginal ultrasound at 12 weeks of gestation was done to confirm ongoing pregnancy. Biochemical pregnancy, implantation, on-going pregnancy and livebirth rates were compared in both groups.\n\nMiscarriage, complications rate and hysteroscopy tolerability were also analyzed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Patients included in the study must be female with uterus.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with infertility / primary infertility.\n* Women who are about to start an IVF/ICSI cycle with their own eggs.\n* Age greater than or equal to 18 years and less than or equal to 40 years.\n* Women in whom a multiple follicular development will be developed with a short protocol with antagonists or long with agonists, and starting dose of gonadotropins according to clinical criteria.\n* Women with uterine ultrasound without endometrial pathology\n\nExclusion Criteria:\n\n* Ovarian reserve: Antimullerian hormone \\<0.5 ng / dl or Count of antral follicles \\<5 between both ovaries.\n* Myomatous uterus: presence of\\> 2 myomas\\> 4cm or that deform uterine cavity.\n* Uterine malformations.\n* Body mass index (BMI) \\<18 or\\> 30.\n* Polycystic ovarian syndrome: according to European Society of Human Reproduction and Embryology (ESRHE)/Rotterdam 2003 criteria.\n* Moderate-severe endometriosis.\n* Background or presence of pelvic inflammatory disease.\n* Hydrosalpinx not excised or occluded.\n* Hyperprolactinemia, defined as prolactin levels greater than 50 ng / ml.\n* Diagnostic history of endometrial hyperplasia.\n* Severe male factor: severe oligoasthenoteratozoospermia with a sperm cell count (REM) \\<100,000 spermatozoa / ml.\n* Impossibility to apply the treatments provided by the study in the terms established by the protocol.\n* Contraindication for the use of any of the treatments provided in the study.'}, 'identificationModule': {'nctId': 'NCT03173404', 'briefTitle': 'Benefits of Hysteroscopy Prior to Performing a Cycle of in Vitro Fertilization/Intracytoplasmic Sperm Injection', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Investigación Hospital Universitario La Paz'}, 'officialTitle': 'Benefits of Hysteroscopy Prior to Performing a Cycle of in Vitro Fertilization/Intracytoplasmic Sperm Injection', 'orgStudyIdInfo': {'id': '3913'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I', 'description': 'Patients underwent hysteroscopy examination before IVF cycle.', 'interventionNames': ['Procedure: Hysteroscopy']}, {'type': 'NO_INTERVENTION', 'label': 'Group II', 'description': 'Patients underwent direct IVF cycle without previous hysteroscopy.'}], 'interventions': [{'name': 'Hysteroscopy', 'type': 'PROCEDURE', 'description': 'The hysteroscopy is the visualization of the cervical canal and uterine cavity with a camera. Patients randomized to group I underwent hysteroscopy prior to the IVF cycle.', 'armGroupLabels': ['Group I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'La Paz University Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Investigación Hospital Universitario La Paz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}