Ignite Creation Date:
2025-12-24 @ 11:06 PM
Ignite Modification Date:
2026-04-16 @ 1:59 PM
Study NCT ID:
NCT02792569
Status:
COMPLETED
Last Update Posted:
2020-01-30
First Post:
2016-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follicle Activation by Inhibition of the Hippo Pathway
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-29', 'studyFirstSubmitDate': '2016-05-23', 'studyFirstSubmitQcDate': '2016-06-06', 'lastUpdatePostDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'AFC count', 'timeFrame': 'Up to 10 month after auto-transplantation', 'description': 'Number of antral follicles (AFC) at the biopsy side versus that of the contralateral side'}, {'measure': 'AMH changes', 'timeFrame': 'Up up to 10 month after auto-transplantation', 'description': 'Changes (increase - decrease) in serum AMH over time, using the highly sensitive new AMH Assay (Elecsys Assay; Roche), which has been implemented as a routine analysis at The Department of Clinical Biochemistry Rigshospitalet in June 1st 2015'}, {'measure': 'Pregnancy', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Numbers of pregnancies (spontaneously/assisted)'}], 'primaryOutcomes': [{'measure': 'Number of follicles > 12 mm', 'timeFrame': 'Up to 6 month after the auto-transplantation', 'description': 'Number of follicles \\> 12 mm in response to controlled ovarian stimulation with corifollitropin from the biopsied ovary versus the contralateral untreated ovary'}], 'secondaryOutcomes': [{'measure': 'Side of ovulation', 'timeFrame': 'Up to 6 months after auto-transplantation', 'description': 'Frequency of ovulations occurring at the "biopsy side" versus the contralateral side in the subsequent 4- 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IVA', 'Hippo Pathway', 'Follicle activation', 'Low Responder', 'POI', 'Poor Ovarian Reserve', 'Poor Ovarian Response', 'Salvador/Warts/Hippo pathway'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '24082083', 'type': 'BACKGROUND', 'citation': 'Kawamura K, Cheng Y, Suzuki N, Deguchi M, Sato Y, Takae S, Ho CH, Kawamura N, Tamura M, Hashimoto S, Sugishita Y, Morimoto Y, Hosoi Y, Yoshioka N, Ishizuka B, Hsueh AJ. Hippo signaling disruption and Akt stimulation of ovarian follicles for infertility treatment. Proc Natl Acad Sci U S A. 2013 Oct 22;110(43):17474-9. doi: 10.1073/pnas.1312830110. Epub 2013 Sep 30.'}, {'pmid': '25202833', 'type': 'BACKGROUND', 'citation': 'Hsueh AJ, Kawamura K, Cheng Y, Fauser BC. Intraovarian control of early folliculogenesis. Endocr Rev. 2015 Feb;36(1):1-24. doi: 10.1210/er.2014-1020. Epub 2014 Sep 9.'}, {'pmid': '25567618', 'type': 'BACKGROUND', 'citation': 'Suzuki N, Yoshioka N, Takae S, Sugishita Y, Tamura M, Hashimoto S, Morimoto Y, Kawamura K. Successful fertility preservation following ovarian tissue vitrification in patients with primary ovarian insufficiency. Hum Reprod. 2015 Mar;30(3):608-15. doi: 10.1093/humrep/deu353. Epub 2015 Jan 6.'}, {'pmid': '31593582', 'type': 'DERIVED', 'citation': 'Lunding SA, Pors SE, Kristensen SG, Landersoe SK, Jeppesen JV, Flachs EM, Pinborg A, Macklon KT, Pedersen AT, Andersen CY, Andersen AN. Biopsying, fragmentation and autotransplantation of fresh ovarian cortical tissue in infertile women with diminished ovarian reserve. Hum Reprod. 2019 Oct 2;34(10):1924-1936. doi: 10.1093/humrep/dez152.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this project is to activate recruitment and growth of resting primordial follicles in the ovaries of women with diminished ovarian reserve, in attempt to increase the chance to become pregnant, either naturally or after assisted reproduction.', 'detailedDescription': 'For this study investigators will carefully select 20 women with low AMH and imminent POI.\n\nThey will be randomized to have cortical ovarian biopsies taken from either the left or right ovary. The biopsies will be fragmented in 1x1 mm2 pieces and immediately auto-transplanted in a peritoneal pocket under the right ovary.\n\nThe contralateral untouched ovary will act as the control, making each woman their own control.\n\nFollow up: each week in 2,5 months the women will be assessed by transvaginal ultrasound and hormonal status. After 2,5-6 months the women will receive a FSH stimulation cycle (rFSH 300 IU or Corifollitropin) followed by standard IVF/ICSI,\n\nHypothesis: the ovaries contain a pool of resting primordial follicles. By fragmentation of cortical ovarian tissue, manipulation of the local environment in the tissue will inhibit the Hippo Pathway and hereby active recruitment and growth of primordial follicles.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infertility with indication for IVF/ICSI\n* Imminent POI, still cycling\n* Age 25 - 39 years\n* Two ovaries\n* Serum AMH measurements \\< 5 pmol/l (two independent measurements)\n* Antral follicle count (AFC) (sum of both ovaries \\< 5)\n\nExclusion Criteria:\n\n* Ovarian pathology (endometriosis, cysts)\n* Known chromosomal abnormality\n* Known autoimmune disease (except TPO-antibodies)\n* Patients who have contraindication for laparoscopy'}, 'identificationModule': {'nctId': 'NCT02792569', 'briefTitle': 'Follicle Activation by Inhibition of the Hippo Pathway', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Auto-transplantation of Fragmented Ovarian Cortical Tissue in Infertile Patients With Premature Ovarian Oocyte Depletion - a Study to Promote Follicular Activation and Subsequent Fertility', 'orgStudyIdInfo': {'id': 'H-15011975'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biopsy at Right side', 'description': 'Biopsy of ovarian cortical tissue (50% right side)', 'interventionNames': ['Procedure: Biopsy of ovarian cortical tissue']}, {'type': 'EXPERIMENTAL', 'label': 'Biopsy at Left side', 'description': 'Biopsy of ovarian cortical tissue (50% left side)', 'interventionNames': ['Procedure: Biopsy of ovarian cortical tissue']}], 'interventions': [{'name': 'Biopsy of ovarian cortical tissue', 'type': 'PROCEDURE', 'description': 'Biopsies will be taken from either right or left side. The cortical tissue will be isolated and fragmented in 1x1 mm2 pieces, followed by auto-transplantation to a peritoneal pocket.', 'armGroupLabels': ['Biopsy at Left side', 'Biopsy at Right side']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'The Fertility Clinic, Rigshospitalet, Copenhagen University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Anders N Andersen, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anders Nyboe Andersen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor M.D.', 'investigatorFullName': 'Anders Nyboe Andersen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}