Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-25 @ 2:56 PM
Study NCT ID:
NCT03579550
Status:
UNKNOWN
Last Update Posted:
2019-03-13
First Post:
2018-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011271', 'term': 'Pregnancy, Ectopic'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective randomised trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-11', 'studyFirstSubmitDate': '2018-06-26', 'studyFirstSubmitQcDate': '2018-06-26', 'lastUpdatePostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical pregnancy rate (CPR)', 'timeFrame': '9 months', 'description': 'Intrauterine gestational sac with viable fetal heart rate'}], 'secondaryOutcomes': [{'measure': 'abortion', 'timeFrame': '10 weeks', 'description': 'the loss of pregnancy'}, {'measure': 'ectopic pregnancy rate', 'timeFrame': '10 weeks', 'description': 'gestation with out of uterine cavity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dysmorphic uterus, metroplasty, hysteroscopy'], 'conditions': ['Hysteroscopy', 'Pregnancy Rate', 'Abortion', 'Ectopic Pregnancy', 'Intrauterine Insemination']}, 'descriptionModule': {'briefSummary': 'The correlation between dysmorphic uterus and infertility still remains enigmatic. We aim to evaluate the reproductive outcomes of metroplasty via office hysteroscopy in unexplained infertile women with dysmorphic uterus with comparing a group of unexplained infertile women performing 6 months spontaneous cycles plus 3 cycles controlled ovarian hyperstimulation and intrauterine insemination by randomized trial.', 'detailedDescription': 'A dysmorphic uterus is a second-class (Class U1) uterine anomaly in the The European Society of Human Reproduction and Embryology (ESHRE) and the European Society for Gynaecological Endoscopy (ESGE) (ESHRE/ESGE) consensus on the classification of congenital genital tract anomalies, which was formerly known as "T-shaped uterus" in the American Fertility Society (AFS) Classification of Anomalies of the Müllerian Duct that leads to poor reproductive and obstetric outcomes.\n\nThe reproductive performance of dysmorphic uterus is not well-known issue. We designed a randomized trial in unexplained infertile couples women with dysmorphic uterus. After allocation of properly selected women, hysteroscopy group will be undertaken metroplasty procedure and 9 months follow-up period with natural conception. Second group will be undertaken to six months spontaneous coitus and three cycles clomiphene citrate and intrauterine insemination cycles. After nine months of follow-up of both groups, the pregnancy and reproductive outcomes will be evaluated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'women with dysmorphic uterus', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nUnexplained infertile couples with;\n\n1. Dysmorpic uterus in hysterosalpingography\n2. Normal spermiogram\n\n2\\. Bilateral patent tubes in hysterosalpingography 3. Normal ovarian reserve (AMH \\>1.5 ng/dl and/or total bilateral antral follicle count \\>8)\n\nExclusion Criteria:\n\n1. Women with history of pelvic surgery including endometriosis and/or tubal surgery\n2. women with endometrioma which was visualised/suspected on transvaginal ultrasonography\n3. Women with anovulation\n4. Women with diminished ovarian reserve (AMH \\< 1.5 ng/dl and/or total bilateral antral follicle count \\<8)\n5. Couples with abnormal spermiogram parameters (oligospermia, oligoasthenospermia, oligoasthenoteratozoospermia, azospermia)\n6. Women with alive children\n7. Obese women (BMI\\>30 kg/m2)'}, 'identificationModule': {'nctId': 'NCT03579550', 'acronym': 'COH/IUI', 'briefTitle': 'Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus', 'organization': {'class': 'OTHER', 'fullName': 'Baskent University'}, 'officialTitle': 'The Comparison of Reproductive Outcomes of Hsyteroscopic Metroplasty Versus Spontaneous Coitus Plus COH/IUI Cycles in Unexplained Infertile Women With Dysmorphic Uterus', 'orgStudyIdInfo': {'id': 'KA17/151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention arm: Hysterocopy group', 'description': 'Office hyteroscopic metroplasty will be performed. After oparetion 9 months spontaneous conception Intervention arm for hysteroscopy group', 'interventionNames': ['Procedure: office hysteroscopic metroplasty intervention arm']}, {'type': 'NO_INTERVENTION', 'label': 'Spontaneous cycles plus COH/IUI', 'description': 'Six months spontaneous coitus cycles plus 3 cycles of Clomiphene citrate and intrauterine insemination (COH/IUI)'}], 'interventions': [{'name': 'office hysteroscopic metroplasty intervention arm', 'type': 'PROCEDURE', 'otherNames': ['spontaneous coitus plus COH/IUI'], 'description': 'One group will be performed hysteroscopic metroplasty Second group will be undertaken to six months spontaneous coitus and three cycles of COH/IUI', 'armGroupLabels': ['Intervention arm: Hysterocopy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01120', 'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Bulent Haydardedeoglu', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}], 'overallOfficials': [{'name': 'Bulent Haydardedeoglu, Assoc.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baskent University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bulent Haydardedeoglu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Prof. M.D.', 'investigatorFullName': 'Bulent Haydardedeoglu', 'investigatorAffiliation': 'Baskent University'}}}}