Mitochondria Transfer from Adipose Stem Cells Improves the Developmental Potential of Cryopreserved Oocytes.
Udayanga Sanath Kankanam Gamage, Shu Hashimoto, Yuki Miyamoto...
https://pubmed.ncbi.nlm.nih.gov/35883564Actively Recruiting
Phase Not Applicable
Age: 29Years - 39Years
FEMALE
ID07066267
Clinical Application of Autologous Adipose Stem Mitochondria Transplantation to Oocytes for Improving Embryo Quality in Patients With Recurrent Pregnancy Failure
Led by Sunkaky Medical Cooperation · Updated on 2025-07-17
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Sunkaky Medical Cooperation
Lead Sponsor
W
Wish Fertility Hospital Pvt. Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the potential of transferring mitochondria from a woman's own adipose stem cells to her oocytes during intracytoplasmic sperm injection (ICSI) to improve embryo development and increase the success rate for women who have experienced multiple failed IVF attempts. Embryo quality is crucial for successful assisted reproductive technologies, and factors such as age and genetics can affect this. Since oocytes depend heavily on mitochondria for energy, boosting mitochondrial content may enhance embryo quality in patients with repeated IVF failures. In this study, mature sibling oocytes will be randomly divided into two groups. One group will undergo conventional ICSI, while the other group will receive mitochondria transplanted from adipose-derived stem cells together with ICSI (called Mito-ICSI). Viable blastocysts from both groups will be biopsied for genetic testing to check for chromosome abnormalities. This randomized, double-blind study compares the outcomes of these two approaches. Participants will provide adipose tissue samples through subcutaneous liposuction and consent to have all embryos frozen and biopsied for genetic testing. Researchers will monitor embryo development rates up to 8 weeks after the procedure and track pregnancy outcomes, such as clinical pregnancy rates, live births, and complications, over up to 24 months. The study involves close monitoring and assessments to evaluate the effects of the mitochondrial transfer on embryo quality and pregnancy success.
CONDITIONS
Brief Title
Adipose Stem Cell Mitochondria Supplementation to Oocytes (ASCENT)
Who Can Participate
Age: 29Years - 39Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Having at least three previous failed IVF trials
- Specifically consented to collect biopsies for Preimplantation Genetic Testing for Aneuploidy (PGTA) analysis
- Specifically consented to have single blastocyst transfer (recommended)
- No major uterine or ovarian abnormalities
- Specifically consented to have all embryos frozen
- Specifically consented to collect adipose tissues from subcutaneous liposuction
- Body mass index (BMI) less than 26 kg/m2
You will not qualify if you...
- Ovarian endometriosis with Chocolate cysts, American Fertility Society (AFS) classification type 3 or 4
- Any medical contraindication for oocyte retrieval or subsequent procedures including ovarian hyperstimulation syndrome, bleeding disorders, sex hormone allergies, severe emotional defects related to injections
- Severe sperm abnormalities
- Less than 5 million motile sperm per milliliter
- Uterine structural anomalies
- Polycystic ovaries
- Premature ovarian failure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 8 weeks
Participants undergo ovarian stimulation, adipose tissue collection by liposuction, and oocyte retrieval. Mature oocytes are divided into two groups: one group receives conventional intracytoplasmic sperm injection (ICSI), and the other group receives mitochondria transplantation from autologous adipose stem cells along with ICSI (Mito-ICSI).
Several visits for ovarian stimulation, liposuction, oocyte retrieval, and embryo biopsy procedures
Follow-up
Duration - Up to 24 months post-intervention
Participants are followed for pregnancy outcomes, including clinical pregnancy and live birth rates, as well as monitoring for pregnancy complications and abortion.
Periodic visits for pregnancy monitoring and assessments
Trial Site Locations
Total: 1 location
1
Wish Fertility Hospital Pvt. Ltd
Colombo, Sri Lanka
Actively Recruiting
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Research Team
D
Dr. SANATHUDAYANGA KANKANAMGAMAGE, PhD
D
Dr. HELARUWAN PASAN KUMARA WA, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Supplementation with autologous adipose stem cell-derived mitochondria can be a safe and promising strategy for improving oocyte quality.
Sanath Udayanga Kankanam Gamage, Shu Hashimoto, Yuki Miyamoto...
https://pubmed.ncbi.nlm.nih.gov/38777961Mitochondrial Transfer into Human Oocytes Improved Embryo Quality and Clinical Outcomes in Recurrent Pregnancy Failure Cases.
Yoshiharu Morimoto, Udayanga Sanath Kankanam Gamage, Takayuki Yamochi...
https://pubmed.ncbi.nlm.nih.gov/36769061