Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT07066267
Status:
RECRUITING
Last Update Posted:
2025-07-17
First Post:
2025-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adipose Stem Cell Mitochondria Supplementation to Oocytes (ASCENT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'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': 'D007246', 'term': 'Infertility'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a triple-blind (Patient, Embryologist, Doctor), single-center, randomized, controlled experimental pilot study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2025-07-04', 'studyFirstSubmitQcDate': '2025-07-04', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Embryo development rate', 'timeFrame': 'Up to 8 weeks post-intervention', 'description': 'Analyze and compare the transferable embryo rate per zygote on day 3 \\& day 5 between the Intervention and control groups.'}], 'secondaryOutcomes': [{'measure': 'Ongoing clinical pregnancy rate after the first transfer', 'timeFrame': 'Up to 18 months post-intervention', 'description': 'Compare ongoing clinical pregnancy rates between the intervention and conrolgroups'}, {'measure': 'Chemical pregnancy rate', 'timeFrame': 'Up to 18 months post-intervention', 'description': 'Compare the chemical pregnancy rates between the two groups.'}, {'measure': 'Live Birth rates', 'timeFrame': 'Up to 24 months post-intervention', 'description': 'Compare live Birth rate following the intervention in both groups'}, {'measure': 'Pregnancy complication', 'timeFrame': 'Up to 24 months post-intervention', 'description': 'Rate of pregnancy complication in both groups'}, {'measure': 'Abortion rate', 'timeFrame': 'Up to 24 months post-intervention', 'description': 'Compare the abortion rates in both groups'}, {'measure': 'Additional in vitro fertilization - outcome indicators', 'timeFrame': 'Up to 8 weeks post-intervention', 'description': 'Compare the rate of fertilization in between two groups'}, {'measure': 'Additional in vitro fertilization - outcome indicators', 'timeFrame': 'Up to 8 weeks post-intervention', 'description': 'Rate of abnormal fertilization in both groups'}, {'measure': 'Additional in vitro fertilization - outcome indicators', 'timeFrame': 'Up to 8 weeks post-intervention', 'description': 'The rate of non-transferable embryos in both groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mitochondria', 'mitochondria transplantation', 'Adipose stem cell', 'oocyte', 'Female infertility'], 'conditions': ['Female Infertility', 'Oocyte Competence', 'Mitochondria', 'Recurent Implantation Failures', 'Advanced Age']}, 'referencesModule': {'references': [{'pmid': '35883564', 'type': 'RESULT', 'citation': 'Kankanam Gamage US, Hashimoto S, Miyamoto Y, Nakano T, Yamanaka M, Koike A, Satoh M, Morimoto Y. Mitochondria Transfer from Adipose Stem Cells Improves the Developmental Potential of Cryopreserved Oocytes. Biomolecules. 2022 Jul 21;12(7):1008. doi: 10.3390/biom12071008.'}, {'pmid': '38777961', 'type': 'RESULT', 'citation': 'Kankanam Gamage SU, Hashimoto S, Miyamoto Y, Nakano T, Yamanaka M, Kitaji H, Takada Y, Matsumoto H, Koike A, Satoh M, Ichishi M, Watanabe M, Morimoto Y. Supplementation with autologous adipose stem cell-derived mitochondria can be a safe and promising strategy for improving oocyte quality. J Assist Reprod Genet. 2024 Aug;41(8):2065-2077. doi: 10.1007/s10815-024-03137-2. Epub 2024 May 22.'}, {'pmid': '36769061', 'type': 'RESULT', 'citation': 'Morimoto Y, Gamage USK, Yamochi T, Saeki N, Morimoto N, Yamanaka M, Koike A, Miyamoto Y, Tanaka K, Fukuda A, Hashimoto S, Yanagimachi R. Mitochondrial Transfer into Human Oocytes Improved Embryo Quality and Clinical Outcomes in Recurrent Pregnancy Failure Cases. Int J Mol Sci. 2023 Feb 1;24(3):2738. doi: 10.3390/ijms24032738.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to investigate the potential of autologous adipose stem cell (ASC) mitochondrial transfer (ASCENT) to oocytes along with intracytoplasmic sperm injection (ICSI)as a means of enhancing embryo development and improving the success rate of in patients with a history of multiple IVF failures. Embryo quality plays a crucial role in determining the success of assisted reproductive technologies and directly contributes to repeated pregnancy failures. Several factors, including age, physiological conditions, genetics, and environmental influences, can significantly impact embryo quality. Oocytes, the largest cells in the human body, are heavily reliant on mitochondria. Mitochondria's role in providing energy for oocytes is crucial, and insufficient energy production has been linked to poor oocyte and embryo quality. Some human studies have shown that increasing oocyte mitochondrial mass can improve embryo quality in patients who have experienced repeated IVF failures.", 'detailedDescription': 'Sibling mature oocytes will be randomly divided into two groups. And one group of oocytes will be undergone conventional intracytoplasmic sperm injection (ICSI) (control group; cont. ICSI) and the other group of oocytes will be undergone mitochondria transplantation along with intracytoplasmic sperm injection (Mito-ICSI). Viable blastocysts from both groups will be biopsied for preimplantation genetic testing for aneuploidy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '29 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having at least three previous failed IVF trial\n* Specifically consented for to collect biopsies for Preimplantation generic testing for aneuploidy (PGTA) analysis\n* Specifically consented for to have single blastocyst transfer (recommended)\n* No major uterine or ovarian abnormalities\n* Specifically consented for to have all embryos frozen\n* Specifically consented for to collect adipose tissues from subcutaneous liposuction\n* BMI level level \\<26kg/m2\n\nExclusion Criteria:\n\n* Ovarian endometriosis with Chocolate cysts (American Fertility Society (AFS)) classification type 3 and 4\n* Any medical contraindication oocyte retrieval or subsequent procedures Ovarian hyperstimulation syndrome Bleeding disorders Sex hormone allergies Severe emotional defect on injections\n* Severe sperm abnormalities\n* \\<5 million/mL motile sperm\n* Uterine structural anomalies\n* Polycystic ovaries\n* Premature ovarian failure'}, 'identificationModule': {'nctId': 'NCT07066267', 'briefTitle': 'Adipose Stem Cell Mitochondria Supplementation to Oocytes (ASCENT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sunkaky Medical Cooperation'}, 'officialTitle': 'Clinical Application of Autologous Adipose Stem Mitochondria Transplantation to Oocytes for Improving Embryo Quality in Patients With Recurrent Pregnancy Failure', 'orgStudyIdInfo': {'id': 'WishREC/24-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Autologous Mitochondria transfer', 'description': 'Mitochondria isolated from autologous adipose-derived stem cells are transplanted into the oocyte in conjunction with intracytoplasmic sperm injection (ICSI); Mito-ICSI group', 'interventionNames': ['Other: Experimental']}, {'type': 'NO_INTERVENTION', 'label': 'Conventonal Intracytoplasmic Sperm Injection', 'description': 'Conventional ICSI; Control group'}], 'interventions': [{'name': 'Experimental', 'type': 'OTHER', 'description': 'Autologous adipose stem cell mitochondrial transfer to mature oocytes along with intracytoplasmic sperm injection (ICSI). The intervention is also termed as Adipose Stem Cell ENergy Transfer (ASCENT).', 'armGroupLabels': ['Autologous Mitochondria transfer']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Colombo', 'status': 'RECRUITING', 'country': 'Sri Lanka', 'facility': 'Wish Fertility Hospital Pvt. Ltd', 'geoPoint': {'lat': 6.93548, 'lon': 79.84868}}], 'centralContacts': [{'name': 'Dr. SANATHUDAYANGA KANKANAMGAMAGE, PhD', 'role': 'CONTACT', 'email': 'udayanga646@ivfjapan.com', 'phone': '+818014361766'}, {'name': 'Dr. HELARUWAN PASAN KUMARA WA, MD, PhD', 'role': 'CONTACT', 'email': 'helaruwanpasankumara@gmail.com', 'phone': '+94 77 327 3866, +9477 478 878'}], 'overallOfficials': [{'name': 'Dr. Helaruwan Pasan Kumara WA, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wish Fertility Hospital Pvt. Ltd'}, {'name': 'Prof. Yoshiharu Morimoto, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Horac Grand Front Osaka Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunkaky Medical Cooperation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Wish Fertility Hospital Pvt. Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}