Adding mitochondria from your own fat stem cells to eggs to try to improve IVF success
Official title: Clinical Application of Autologous Adipose Stem Mitochondria Transplantation to Oocytes for Improving Embryo Quality in Patients With Recurrent Pregnancy Failure
Run by Sunkaky Medical Cooperation · NCT07066267 · Data updated 2026-11-12
This procedure will try adding mitochondria from your own adipose (fat) stem cells into eggs during ICSI to see if embryo quality and pregnancy rates improve for people with multiple prior IVF failures.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 29 Years to 39 Years |
| Sex | Women only |
| Enrollment | 20 (estimated) |
| Sponsor | Sunkaky Medical Cooperation Industry-sponsored |
| Locations | 1 site (Colombo) |
| Status | Recruiting |
| Started | April 25, 2025 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | July 17, 2025 |
| Trial ID | NCT07066267 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with at least three prior failed IVF cycles, BMI under 26 kg/m2, no major uterine or ovarian abnormalities, adequate sperm parameters, and who are willing to undergo adipose liposuction and PGT-A with single blastocyst transfer.
✕Probably not a fit
Patients with premature ovarian failure, severe sperm abnormalities (including motile sperm <5 million/mL), significant uterine or ovarian pathology (such as AFS type 3–4 endometriomas), polycystic ovaries, or a BMI ≥26 are excluded and unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Sibling mature oocytes from each participant are randomly divided: one group receives conventional ICSI and the other receives mitochondrial transfer from autologous adipose-derived stem cells plus ICSI (Mito-ICSI). Mitochondria are obtained from subcutaneous liposuction–harvested adipose stem cells and injected into oocytes at the time of ICSI. Viable blastocysts from both groups are biopsied for PGT-A and embryos are frozen, with single blastocyst transfer recommended. The trial enrolls patients with at least three prior failed IVF cycles and excludes those with major uterine or ovarian abnormalities, severe sperm defects, premature ovarian failure, or BMI ≥26.
Why it matters
Potential benefit: If successful, this approach could improve embryo quality and increase pregnancy and live birth rates for people who have had repeated IVF failures.
How similar studies have gone: Small human studies of increasing oocyte mitochondrial mass have shown some improvements in embryo quality, but mitochondrial supplementation remains experimental and not widely validated in large trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Wish Fertility Hospital Pvt. Ltd
Colombo, Sri Lanka Recruiting
Study contacts
- Principal investigator: Dr. Helaruwan Pasan Kumara WA, MD, PhD — Wish Fertility Hospital Pvt. Ltd
- Study coordinator: Dr. SANATHUDAYANGA KANKANAMGAMAGE, PhD
- Email: udayanga646@ivfjapan.com
- Phone: +818014361766
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.