Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2026-04-25 @ 8:18 AM
Study NCT ID:
NCT03298750
Status:
UNKNOWN
Last Update Posted:
2017-10-10
First Post:
2016-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanical Stimulation of the Ovary for Infertility Treatment in Patients With Very Low Ovarian Reserve
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-10-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-09', 'studyFirstSubmitDate': '2016-06-26', 'studyFirstSubmitQcDate': '2017-09-26', 'lastUpdatePostDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Menstrual cycle surveillance', 'timeFrame': '2 years', 'description': 'Duration of the menstrual period (days)'}, {'measure': 'AMH', 'timeFrame': '2 years', 'description': 'Ovarian reserve measurements. AMH levels ng/ml'}, {'measure': 'Estradiol', 'timeFrame': '2 years', 'description': 'Estradiol levels at day of HCG in Pmol/L'}, {'measure': 'Antral follicular count', 'timeFrame': '2 years', 'description': 'measurement of. any antral follicles at day 3-5 with ultrasound'}, {'measure': 'IVF outcomes', 'timeFrame': '2 years', 'description': 'Number of oocytes at OPU'}, {'measure': 'FSH levels', 'timeFrame': '2 years', 'description': 'FSH levels at. day 2-3 of menstruation IU/L'}, {'measure': 'IVF outcomes fertilization rates', 'timeFrame': '2 years', 'description': 'fertilization rate. - number of fertilized oocytes relatively to total number of oocytes'}, {'measure': 'IVF outcomes', 'timeFrame': '2 years', 'description': 'pregnancy rates'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mechanical Laboratory Ovarian Stimulation Poor responders'], 'conditions': ['Ovarian Stimulation']}, 'descriptionModule': {'briefSummary': 'Examine the possibility that mechanical stimulation and ovarian fragmentation in women with premature ovarian failure or low ovarian reserve intended for egg donation may cause early follicular recruitment and increase chances of achieving pregnancy through IVF.', 'detailedDescription': "The women will undergo a surgical laparoscopy during which one of the two technique will ensue.\n\n1. One of the ovaries will be scratched ( 2 mm depth) with a knife. Simultaneously, a piece of the ovary will be preserved for further histologic analysis and research in the laboratory.\n2. A piece of one ovary will be resected (up to one third of the ovary's volume, without harming the other ovary.\n\nThe resected ovarian tissue will be transferred immediately to the laboratory where the cortex will be divided from the medulla and sliced to small pieces of 1-2 square millimeters.\n\nThese pieces will be transferred back to the operation room in order for them to be transplanted under the serosa layer of the remaining ovary.\n\nAny bleeding would be stopped using a stiches or hemostatic mesh (diathermy will not be used).\n\nSimultaneously, a piece of the ovary will be preserved for further histologic analysis and research in the laboratory.\n\nPost operational follow up ( up to two years) including: menstrual cycle surveillance, hormonal profile, AMH level, US of the pelvis and Antral Follicles Count (AFC).\n\nA month after the surgery, an ovarian stimulation will commence following IVF while close monitoring the ovarian response and comparing the pre and post operation response.\n\nMoreover, the treated ovary will be compared to the untreated one: using the US the ovarian volume and antral follicles size and count will be evaluated.\n\nThe preserved pieces of ovary will be histologically evaluated for ovarian reserve analysis.\n\nAdditionally, these pieces will be used for experiments for the evaluation of various methods for primordial follicles stimulation including mechanical stimulation like the laser or using substances like Akt Stimulators."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy women, aged 21-40. with premature ovarian failure.\n* Healthy women, with poor ovarian reserve, aged 38-45, undergoing IVF Low ovarian response: recruitment of up to three eggs in previous treatments.\n* After the failure of at least 4 cycles.\n* Two functioning ovaries, follicular and hormonal response of both ovaries in prior therapies.\n* Women candidates for egg donation, and seeking further treatment before switching to egg donation.\n\nExclusion Criteria:\n\n* Women with kidney disease.\n* Women with infertility factors other than ovarian failure, such as endometriosis, PCOS, male factor.\n* Women with one non-functioning ovary, or that was removed.\n* Women with an intrauterine or pelvic pathology.'}, 'identificationModule': {'nctId': 'NCT03298750', 'briefTitle': 'Mechanical Stimulation of the Ovary for Infertility Treatment in Patients With Very Low Ovarian Reserve', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Mechanical Stimulation of the Ovary for Infertility Treatment in Patients With Very Low Ovarian Reserve', 'orgStudyIdInfo': {'id': 'SHEBA-15-2289-AK-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mechanical stimulation', 'description': 'Mechanical stimulation of ovarian tissue', 'interventionNames': ['Procedure: Resection of ovarian tissue and mechanical stimulation']}], 'interventions': [{'name': 'Resection of ovarian tissue and mechanical stimulation', 'type': 'PROCEDURE', 'description': "he women will undergo a surgical laparoscopy during which one of the two technique will ensue.\n\n1. One of the ovaries will be scratched ( 2 mm depth) with a knife. Simultaneously, a piece of the ovary will be preserved for further histologic analysis and research in the laboratory.\n2. A piece of one ovary will be resected (up to one third of the ovary's volume, without harming the other ovary.\n\nThe resected ovarian tissue will be transferred immediately to the laboratory where the cortex will be divided from the medulla and sliced to small pieces of 1-2 square millimeters.\n\nThese pieces will be transferred back to the operation room in order for them to be transplanted under the serosa layer of the remaining ovary.\n\nAny bleeding would be stopped using a stiches or hemostatic mesh (diathermy will not be used).\n\nSimultaneously, a piece of the ovary will be preserved for further histologic analysis and research in the laboratory.", 'armGroupLabels': ['Mechanical stimulation']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Alon Kedem, MD', 'role': 'CONTACT', 'email': 'kedem2001@gmail.com', 'phone': '972543456953'}, {'name': 'Noam Domniz, MD', 'role': 'CONTACT', 'email': 'domniz@gmail.com', 'phone': '972528899242'}], 'overallOfficials': [{'name': 'Alon Kedem, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}