Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-25 @ 12:51 PM
Study NCT ID:
NCT04608695
Status:
UNKNOWN
Last Update Posted:
2022-09-21
First Post:
2020-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ovarian Needle Puncture for Follicle Activation in IVF Patients With Diminished Ovarian Reserve
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016649', 'term': 'Primary Ovarian Insufficiency'}], 'ancestors': [{'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-18', 'studyFirstSubmitDate': '2020-10-25', 'studyFirstSubmitQcDate': '2020-10-25', 'lastUpdatePostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of ≥14 mm follicle', 'timeFrame': '4 month after intervention as a response to ovarian stimulation', 'description': 'Number of ≥14 mm follicle on the trigger day'}, {'measure': 'Antral follicle count', 'timeFrame': '4 month after intervention on the second/third day of menstrual cycle', 'description': 'Antral follicle count'}], 'secondaryOutcomes': [{'measure': 'Number of collected oocytes', 'timeFrame': '4 month after intervention as a response to ovarian stimulation', 'description': 'Number of collected oocytes on the oocyte pick-up day'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Follicle Activation', 'Premature Ovarian Insufficiency', 'Diminished Ovarian Reserve', 'Ovarian Puncture'], 'conditions': ['Activation of Primordial Follicles']}, 'referencesModule': {'references': [{'pmid': '20708256', 'type': 'BACKGROUND', 'citation': 'De Vos M, Devroey P, Fauser BC. Primary ovarian insufficiency. Lancet. 2010 Sep 11;376(9744):911-21. doi: 10.1016/S0140-6736(10)60355-8. Epub 2010 Aug 11.'}, {'pmid': '29225794', 'type': 'BACKGROUND', 'citation': 'Torrealday S, Kodaman P, Pal L. Premature Ovarian Insufficiency - an update on recent advances in understanding and management. F1000Res. 2017 Nov 29;6:2069. doi: 10.12688/f1000research.11948.1. eCollection 2017.'}, {'pmid': '25008235', 'type': 'BACKGROUND', 'citation': 'Ferraretti AP, Gianaroli L. The Bologna criteria for the definition of poor ovarian responders: is there a need for revision? Hum Reprod. 2014 Sep;29(9):1842-5. doi: 10.1093/humrep/deu139. Epub 2014 Jul 9.'}, {'pmid': '27177971', 'type': 'BACKGROUND', 'citation': 'Bachelot A, Nicolas C, Bidet M, Dulon J, Leban M, Golmard JL, Polak M, Touraine P. Long-term outcome of ovarian function in women with intermittent premature ovarian insufficiency. Clin Endocrinol (Oxf). 2017 Feb;86(2):223-228. doi: 10.1111/cen.13105. Epub 2016 Jun 14.'}, {'pmid': '26825246', 'type': 'BACKGROUND', 'citation': 'Chen X, Chen SL, Ye DS, Liu YD, He YX, Tian XL, Xu LJ, Tao T. Retrospective analysis of reproductive outcomes in women with primary ovarian insufficiency showing intermittent follicular development. Reprod Biomed Online. 2016 Apr;32(4):427-33. doi: 10.1016/j.rbmo.2015.12.011. Epub 2016 Jan 14.'}, {'pmid': '27022685', 'type': 'BACKGROUND', 'citation': 'Kawamura K, Kawamura N, Hsueh AJ. Activation of dormant follicles: a new treatment for premature ovarian failure? Curr Opin Obstet Gynecol. 2016 Jun;28(3):217-22. doi: 10.1097/GCO.0000000000000268.'}, {'pmid': '30541396', 'type': 'BACKGROUND', 'citation': 'Zhang X, Han T, Yan L, Jiao X, Qin Y, Chen ZJ. Resumption of Ovarian Function After Ovarian Biopsy/Scratch in Patients With Premature Ovarian Insufficiency. Reprod Sci. 2019 Feb;26(2):207-213. doi: 10.1177/1933719118818906. Epub 2018 Dec 12.'}]}, 'descriptionModule': {'briefSummary': "Premature ovarian insufficiency (POI), is cessation of ovarian function characterized by hypergonadotropic amenorrhea and hypoestrogenic syndrome before 40 years of age. About 1% of women younger than 40 years old and 0.1% before 30 are affected. POI imposes a great challenge on women's reproductive and long-term health, such as infertility, amenorrhea, osteoporosis, and cardiovascular disease. Most patients already had impaired or complete loss of fecundity when diagnosed. Currently, no optimal regimen exists to ameliorate ovarian function. Typically, they end up with egg donation or adoption as an alternative way. Less severe form of POI is diminished ovarian reserve (DOR). Although lack of consensus according to Bologna criteria cut off for DOR was defined as (antral follicle count (AFC) \\<5-7 follicles or anti-Mullerian hormone (AMH) \\<0.5-1.1 ng/ml).\n\nPreviously it has been showed that 24% of women with POI had resumption of ovarian function and 4% resulted in baby births. These data indicates residual follicles are available in atrophic ovaries and have potential for development and even fertilization. In routine IVF practice 15% percent of patients have poor ovarian response to ovarian stimulation. Patients with DOR with a previous poor ovarian response (cycles cancelled or yielding ≤3 oocytes with a conventional protocol) might have benefit from the strategies increasing follicle activation and number of growing follicles and oocyte retrieved. Therefore, strategies enabling ovarian resumption predictable and follicle activation feasible are promising for POI/DOR treatment. Recently, In vitro Activation (IVA) approach has been proposed and live births have been achieved in patients with POI. Phosphatase and tensin homolog (PTEN) enzyme inhibitors and phosphatidylinositol-3 kinase activators could activate AKT pathway and activate the dormant follicles. Ovarian fragmentation could lead to ovarian primary follicle growth by interfering with Hippo signaling pathway. Residual follicles in patients with POI could be activated to develop for egg retrieval by combination of mechanical and chemical stimulation.\n\nIn 2019, Zhang et al retrospectively analyzed the follicle development and pregnancy outcome in 80 POI patients after laparoscopic ovarian biopsy/scratch without using chemical agents as was the case in IVA. 11 (13.75%) patients presented with ovarian function resumption, three metaphases II oocytes were retrieved in 10 patients and two embryos were formed and freshly transferred followed by a healthy singleton delivery in 1 (1.25%) patient. They concluded that the technique of ovarian biopsy/scratch without chemical activation could promote follicle development in vivo, suggesting it could bring promising benefits for some women with POI.\n\nIn patient with POI/DOR, activation of residual follicles is a promising option and further studies are warranted. Previous studies included laparoscopic surgery which may lead to possible surgical complications. Without using chemical agents and laparoscopic surgery, main object of this study is mechanical follicle activation with trans-vaginal ovarian needle puncture with 17 gauge oocyte pickup needle in IVF patients with DOR."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diminished ovarian reserve\n* \\<3 oocytes collected in previous cycle (with anti-mullerian hormone \\<0.5 ng/mL and/or antral follicle count \\<5)\n* Cycles stimulated with flexible antagonist protocol\n* Cycles triggered with recombinant hCG\n* Fresh transfer cycles\n* Patients with \\<40 years of age\n* BMI \\<30 kg/m2\n\nExclusion Criteria:\n\n* Preimplantation genetic testing\n* Azospermia'}, 'identificationModule': {'nctId': 'NCT04608695', 'briefTitle': 'Ovarian Needle Puncture for Follicle Activation in IVF Patients With Diminished Ovarian Reserve', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Ovarian Needle Puncture for Follicle Activation in IVF Patients With Diminished Ovarian Reserve', 'orgStudyIdInfo': {'id': 'HU02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control ovary'}, {'type': 'EXPERIMENTAL', 'label': 'Punctured ovary', 'interventionNames': ['Procedure: Ovarian puncture']}], 'interventions': [{'name': 'Ovarian puncture', 'type': 'PROCEDURE', 'description': 'One side ovary of each patient included in the study, will be punctured 10 times under trans-vaginal ultrasound guidance with 17 gauge ovarian pick up needle, 1 month before the scheduled IVF cycle. Control group will be the other side ovary for each patient. Number of ≥ 14 mm follicle and collected oocytes will be compared.', 'armGroupLabels': ['Punctured ovary']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Sezcan Mumusoglu, Assoc. Prof.', 'role': 'CONTACT', 'email': 'sezcanmumusoglu@gmail.com', 'phone': '+905326404673'}, {'name': 'Gurkan Bozdag, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sezcan Mumusoglu, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Esra Uyanık, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Haldun Murat Erden, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hacettepe UniversityHacettepe University School of Medicine, Department of Ob/Gyn', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Sezcan Mumusoglu, Assoc. Prof.', 'role': 'CONTACT', 'email': 'sezcanmumusoglu@gmail.com', 'phone': '+905326404673'}], 'overallOfficials': [{'name': 'Sezcan Mumusoğlu, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sezcan Mumusoglu', 'investigatorAffiliation': 'Hacettepe University'}}}}