Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 11:40 PM
Study NCT ID:
NCT04426760
Status:
UNKNOWN
Last Update Posted:
2020-06-11
First Post:
2020-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fibroids and Infertility - a Study of the Significance of Removal of Fibroids With Regard to Endometrial Receptivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007813', 'term': 'Laparotomy'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Endometrial biopsies Leiomyoma biopsy Serum Plasma Blood cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2024-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-08', 'studyFirstSubmitDate': '2020-06-08', 'studyFirstSubmitQcDate': '2020-06-08', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HOXA 10 expression', 'timeFrame': '3-6 months', 'description': 'Fold change of HOXA 10 Expression 3-6 months after myomectomy compared to pre-surgery Levels'}], 'secondaryOutcomes': [{'measure': 'Expression of other molecular markers', 'timeFrame': '3-6 months', 'description': 'Fold change of other molecular markers than HOXA 10 of endometrial receptivity 3-6 months after myomectomy and compared to fertile/infertile controls'}, {'measure': 'Endometrial vascular pattern', 'timeFrame': '3-6 months', 'description': 'VI and FI of the endometrium and subendometrial myometrium of women with leimyomas 3-6 months after myomectomy and compared to fertile/infertile controls'}, {'measure': 'Vascular characteristics of leiomyomas', 'timeFrame': '3-6 months', 'description': 'Vascular characteristics of leiomyomas associated with endometrial changes'}, {'measure': 'Leiomyoma size', 'timeFrame': '3-6 months', 'description': 'Leiomyomas size in centimeters associated with endometrial changes'}, {'measure': 'Leiomyoma location', 'timeFrame': '3-6 months', 'description': 'Leiomyoma location associated with endometrial changes'}, {'measure': 'Genomic characteristics', 'timeFrame': '3-6 months', 'description': 'Genomic characteristics of leiomyomas associated with endometrial changes'}, {'measure': 'Scar formation', 'timeFrame': '3-6 months', 'description': 'Scar/fibrosis/adhesion formation after myomectomy; macroscopically and histologically'}, {'measure': 'Pregnancy', 'timeFrame': '2 years', 'description': 'Pregnancy and deliveries within 2 years after myomectomy.'}, {'measure': 'HOXA10 in endometrium of women with leiomyomas compared to fertile/infertile controls', 'timeFrame': '3-6 months', 'description': 'Difference in HOXA 10 expression in endometrium of women with leiomyomas compared to fertile/infertile controls'}, {'measure': 'Expression of molecular markers adjacent to the leiomyoma versus remote from the leiomyoma', 'timeFrame': '3-6 months', 'description': 'Difference in expression of molecular markers in endometrium adjacent to the leiomyoma compared to endometrium remote from the leiomyoma.'}, {'measure': 'Partially resected leiomyomas', 'timeFrame': '3-6 months', 'description': 'Alterations in molecular markers of endometrial receptivity after partially resected submucosal leiomyomas.'}, {'measure': 'Submucosal leiomyomas versus intramural leiomyomas', 'timeFrame': '3-6 months', 'description': 'Difference in expression of molecular markers in endometrium of women with submucosal leiomyomas compared with endometrium in women with intramural leiomyomas.'}, {'measure': 'Biomarkers in blood', 'timeFrame': '1 year', 'description': 'Biomarkers in blood related to leiomyomas and a possible correlation between certain biomarkers and reduced endometrial receptivity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infertility', 'Endometrial receptivity', 'Leiomyoma', 'Fibroid'], 'conditions': ['Leiomyoma, Uterine']}, 'descriptionModule': {'briefSummary': 'We aim to explore some of the molecular factors that reduce fertility for women with leiomyomas, taking into account leiomyoma location, size, number and vascularity. Tissue samples from the endometrium and leiomyomas will be obtained during the mid secretory phase before and 3-6 months after surgical excision for a comprehensive search for key molecular derangements.', 'detailedDescription': 'Baseline medical information and standard questionnaire to record symptoms are collected from all participants and a gynaecological examination and a 2D and 3D vaginal ultrasonography including saline infusion sonography (SIS), if indicated, are performed. Blood samples for the biobank for extraction of germ line DNA and for identification of possible biomarkers are taken.\n\nThe women with submucosal leiomyomas will undergo hysteroscopic myomectomy and the women with intramural leiomyomas will undergo myomectomy per laparoscopy or laparotomy.\n\nFor the participants with intramural leiomyomas and the fertile/infertile controls, endometrial samples are taken with an endometrial suction curette in an outpatient setting at day 19-23 of the menstrual cycle. The endometrial sampling in the group of women with submucosal leiomyomas is being done during the hysteroscopic removal of the leiomyoma, also at day 19-23 of the menstrual cycle.\n\n3-6 months after surgery, cycle day 19-23, endometrial samples will be taken from the women who have undergone myomectomy and ultrasound examination is being performed. The women with submucosal leiomyomas will undergo a second look hysteroscopy'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients referred to the Department of Gynaecology at Oslo University Hospital for treatment of submucosal or intramural leiomyomas.', 'genderDescription': 'The biological sex must be female since we are studying a phenomenone occuring in the female genital tract.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18 to 40 years\n* Presence of leiomyoma(s)\n* Regular menstrual cycle (28 +/- 7 days)\n* Having had at least 2 normal menstrual cycles after ending the treatment if previously treated with GnRH analogue\n* Signed informed consent\n\nExclusion Criteria:\n\n* No treatment indication (no symptoms and/or no desire for fertility)\n* Contraindication for surgery\n* Known endometriosis\n* Known PCOS\n* Untreated hydrosalpinx\n* Malignancy; gynaecological or other location\n* Pre-malignant or malignant pap smear or endometrial biopsy\n* Hormonal treatment including ulipristal acetat and levonorgestrel intrauterine device last three months before inclusion in the study\n* Ongoing treatment with GnRH analogue\n* Pregnancy last 3 months\n* Ongoing lactation'}, 'identificationModule': {'nctId': 'NCT04426760', 'acronym': 'FIN', 'briefTitle': 'Fibroids and Infertility - a Study of the Significance of Removal of Fibroids With Regard to Endometrial Receptivity', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Mechanisms of Reduced Fertility in Women With Uterine Leiomyomas', 'orgStudyIdInfo': {'id': '2017/9703'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with submucosal leiomyoma(s)', 'description': 'Women with submucosal leimyomas undergoing hysteroscopical removal of the leiomyoma', 'interventionNames': ['Procedure: Transcervical resection of fibroids']}, {'label': 'Women with intramural leiomyomas', 'description': 'Women with intramural leiomyomas undergoing myomectomy', 'interventionNames': ['Procedure: Myomectomy per laparoscopy or laparotomy']}, {'label': 'Infertility patients', 'description': 'Patients treated at the Department for Reproductive Medicine at the Oslo University hospital failing to conceive after 3 or more embryo transfers with good quality embryos.'}, {'label': 'Fertile women', 'description': 'Healthy, volunteering women with proved fertility with 1 or more deliveries and no history of infertility'}], 'interventions': [{'name': 'Transcervical resection of fibroids', 'type': 'PROCEDURE', 'description': 'Transcervical resection of fibroids', 'armGroupLabels': ['Women with submucosal leiomyoma(s)']}, {'name': 'Myomectomy per laparoscopy or laparotomy', 'type': 'PROCEDURE', 'description': 'Myomectomy per laparoscopy or laparotomy', 'armGroupLabels': ['Women with intramural leiomyomas']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Thea F Mikkelsen, MD', 'role': 'CONTACT', 'email': 'themik@ous-hf.no', 'phone': '004797612934'}, {'name': 'Kirsten Hald, PhD', 'role': 'CONTACT', 'email': 'UXKILD@ous-hf.no', 'phone': '004795224181'}], 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'centralContacts': [{'name': 'Thea F. Mikkelsen, MD', 'role': 'CONTACT', 'email': 'themik@ous-hf.no', 'phone': '004797612934'}, {'name': 'Kirsten Hald, PhD', 'role': 'CONTACT', 'email': 'UXKILD@ous-hf.no', 'phone': '004795224181'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Consultant', 'investigatorFullName': 'Kirsten Hald, MD, PhD', 'investigatorAffiliation': 'Oslo University Hospital'}}}}