Female InfertilityNCT07066267
Adipose Stem Cell Mitochondria Supplementation to Oocytes (ASCENT)
A study testing Experimental in people with Female Infertility and Oocyte Competence, run by Sunkaky Medical Cooperation at 1 site in Sri Lanka.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 29 to 39 years, women only
- Conditions the study is for
- Female Infertility, Oocyte Competence, Mitochondria
- What is being tested?
- Experimental
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSri Lanka
- Study dates
- 25 Apr 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr. HELARUWAN PASAN KUMARA WA, MD, PhD contact
Sri Lanka1 site, 1 recruiting
- Recruiting
Wish Fertility Hospital Pvt. Ltd
Colombo
About this study
Official title: Clinical Application of Autologous Adipose Stem Mitochondria Transplantation to Oocytes for Improving Embryo Quality in Patients With Recurrent Pregnancy Failure
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.
Read the detailed description
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
- Female Infertility, Oocyte Competence, Mitochondria, Recurent Implantation Failures, Advanced Age
- Being tested
- Experimental
- Keywords
- mitochondria, mitochondria transplantation, Adipose stem cell, oocyte, Female infertility
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Autologous Mitochondria transfer | Active comparator | Mitochondria isolated from autologous adipose-derived stem cells are transplanted into the oocyte in conjunction with intracytoplasmic sperm injection (ICSI); Mito-ICSI group Receives: Other: Experimental |
| Conventonal Intracytoplasmic Sperm Injection | No intervention | Conventional ICSI; Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Embryo development rate
Analyze and compare the transferable embryo rate per zygote on day 3 \& day 5 between the Intervention and control groups.
Measured: Up to 8 weeks post-intervention
Secondary outcomes (8)
Ongoing clinical pregnancy rate after the first transfer
Compare ongoing clinical pregnancy rates between the intervention and conrolgroups
Measured: Up to 18 months post-intervention
Chemical pregnancy rate
Compare the chemical pregnancy rates between the two groups.
Measured: Up to 18 months post-intervention
Live Birth rates
Compare live Birth rate following the intervention in both groups
Measured: Up to 24 months post-intervention
Pregnancy complication
Rate of pregnancy complication in both groups
Measured: Up to 24 months post-intervention
Abortion rate
Compare the abortion rates in both groups
Measured: Up to 24 months post-intervention
Additional in vitro fertilization - outcome indicators
Compare the rate of fertilization in between two groups
Measured: Up to 8 weeks post-intervention
Additional in vitro fertilization - outcome indicators
Rate of abnormal fertilization in both groups
Measured: Up to 8 weeks post-intervention
Additional in vitro fertilization - outcome indicators
The rate of non-transferable embryos in both groups
Measured: Up to 8 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start25 Apr 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Female InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a triple-blind (Patient, Embryologist, Doctor), single-center, randomized, controlled experimental pilot study.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunkaky Medical Cooperation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wish Fertility Hospital Pvt. Ltd
- Responsible party
- Sponsor
- Investigators
- Dr. Helaruwan Pasan Kumara WA, MD, PhD, Principal investigator, Wish Fertility Hospital Pvt. LtdProf. Yoshiharu Morimoto, MD, PhD, Principal investigator, Horac Grand Front Osaka Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066267
- Sponsor's protocol ID
- WishREC/24-011
- Status last verified
- Jun 2025
- First submitted
- 4 Jul 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Undecided
Publications
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.
PubMed 35883564Kankanam 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.
PubMed 38777961Morimoto 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.
PubMed 36769061
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Autologous Adipose Stem Mitochondria Transplantation to Oocytes for Improving Embryo Quality in Patients With Recurrent Pregnancy Failure
- ClinicalTrials.gov ID
- NCT07066267
- Acronym / sponsor ID
- WishREC/24-011
- Conditions
- Female Infertility, Oocyte Competence, Mitochondria, Recurent Implantation Failures, Advanced Age
- Keywords
- mitochondria, mitochondria transplantation, Adipose stem cell, oocyte, Female infertility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sunkaky Medical CooperationIndustry (pharma, biotech, devices)
- Collaborators
- Wish Fertility Hospital Pvt. Ltd
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- This is a triple-blind (Patient, Embryologist, Doctor), single-center, randomized, controlled experimental pilot study.
| Arm | Type | Receives |
|---|---|---|
| Autologous Mitochondria transfer | Active comparator | Other: ExperimentalMitochondria isolated from autologous adipose-derived stem cells are transplanted into the oocyte in conjunction with intracytoplasmic sperm injection (ICSI); Mito-ICSI group |
| Conventonal Intracytoplasmic Sperm Injection | No intervention | –Conventional ICSI; Control group |
Who may qualify
- Ages
- 29 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExperimentalAutologous 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). | Other | Autologous Mitochondria transfer |
Primary outcome
Embryo development rate
Time frame: Up to 8 weeks post-intervention
Analyze and compare the transferable embryo rate per zygote on day 3 \& day 5 between the Intervention and control groups.
8 secondary outcomes
Ongoing clinical pregnancy rate after the first transfer
Time frame: Up to 18 months post-intervention
Chemical pregnancy rate
Time frame: Up to 18 months post-intervention
Live Birth rates
Time frame: Up to 24 months post-intervention
Pregnancy complication
Time frame: Up to 24 months post-intervention
Abortion rate
Time frame: Up to 24 months post-intervention
Additional in vitro fertilization - outcome indicators
Time frame: Up to 8 weeks post-intervention
Additional in vitro fertilization - outcome indicators
Time frame: Up to 8 weeks post-intervention
Additional in vitro fertilization - outcome indicators
Time frame: Up to 8 weeks post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Results publication: PubMed 35883564Kankanam 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.
- Results publication: PubMed 38777961Kankanam 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.
- Results publication: PubMed 36769061Morimoto 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.
- Individual participant dataSharing planned: No. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. HELARUWAN PASAN KUMARA WA, MD, PhD contact
Dr. Helaruwan Pasan Kumara WA, MD, PhD principal investigator
Wish Fertility Hospital Pvt. Ltd
Prof. Yoshiharu Morimoto, MD, PhD principal investigator
Horac Grand Front Osaka Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Female Infertility and Oocyte Competence, run by Sunkaky Medical Cooperation at 1 site in Sri Lanka.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sri Lanka. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. SANATHUDAYANGA KANKANAMGAMAGE, PhD (+818014361766, udayanga646@ivfjapan.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Embryo development rate (time frame: Up to 8 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07066267, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.