Adipose Stem Cell Mitochondria Supplementation to Oocytes (ASCENT)
NCT ID: NCT07066267
Last Updated: 2025-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2025-04-25
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Autologous Mitochondria transfer
Mitochondria isolated from autologous adipose-derived stem cells are transplanted into the oocyte in conjunction with intracytoplasmic sperm injection (ICSI); Mito-ICSI group
Experimental
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).
Conventonal Intracytoplasmic Sperm Injection
Conventional ICSI; Control group
No interventions assigned to this group
Interventions
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Experimental
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).
Eligibility Criteria
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Inclusion Criteria
* Specifically consented for to collect biopsies for Preimplantation generic testing for aneuploidy (PGTA) analysis
* Specifically consented for to have single blastocyst transfer (recommended)
* No major uterine or ovarian abnormalities
* Specifically consented for to have all embryos frozen
* Specifically consented for to collect adipose tissues from subcutaneous liposuction
* BMI level level \<26kg/m2
Exclusion Criteria
* Any medical contraindication oocyte retrieval or subsequent procedures Ovarian hyperstimulation syndrome Bleeding disorders Sex hormone allergies Severe emotional defect on injections
* Severe sperm abnormalities
* \<5 million/mL motile sperm
* Uterine structural anomalies
* Polycystic ovaries
* Premature ovarian failure
29 Years
39 Years
FEMALE
No
Sponsors
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Wish Fertility Hospital Pvt. Ltd
UNKNOWN
Sunkaky Medical Cooperation
INDUSTRY
Responsible Party
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Principal Investigators
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Dr. Helaruwan Pasan Kumara WA, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Wish Fertility Hospital Pvt. Ltd
Prof. Yoshiharu Morimoto, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Horac Grand Front Osaka Clinic
Locations
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Wish Fertility Hospital Pvt. Ltd
Colombo, , Sri Lanka
Countries
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Central Contacts
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Dr. HELARUWAN PASAN KUMARA WA, MD, PhD
Role: CONTACT
References
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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.
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.
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.
Other Identifiers
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WishREC/24-011
Identifier Type: -
Identifier Source: org_study_id
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