Adipose Stem Cell Mitochondria Supplementation to Oocytes (ASCENT)

NCT ID: NCT07066267

Last Updated: 2025-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-25

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Female Infertility Oocyte Competence Mitochondria Recurent Implantation Failures Advanced Age

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a triple-blind (Patient, Embryologist, Doctor), single-center, randomized, controlled experimental pilot study.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Experimental

Intervention Type OTHER

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Having at least three previous failed IVF trial
* 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

* Ovarian endometriosis with Chocolate cysts (American Fertility Society (AFS)) classification type 3 and 4
* 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
Minimum Eligible Age

29 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wish Fertility Hospital Pvt. Ltd

UNKNOWN

Sponsor Role collaborator

Sunkaky Medical Cooperation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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

Explore where the study is taking place and check the recruitment status at each participating site.

Wish Fertility Hospital Pvt. Ltd

Colombo, , Sri Lanka

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Sri Lanka

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Dr. SANATHUDAYANGA KANKANAMGAMAGE, PhD

Role: CONTACT

+818014361766

Dr. HELARUWAN PASAN KUMARA WA, MD, PhD

Role: CONTACT

+94 77 327 3866, +9477 478 878

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 35883564 (View on PubMed)

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.

Reference Type RESULT
PMID: 38777961 (View on PubMed)

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.

Reference Type RESULT
PMID: 36769061 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WishREC/24-011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Very Small Embryonic-like Stem Cells for Ovary
NCT03985462 WITHDRAWN PHASE1/PHASE2