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/38777961/Actively Recruiting
Led by Sunkaky Medical Cooperation · Updated on 2025-07-17
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
This research aims to evaluate the potential of transferring mitochondria from a womans 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
Adipose Stem Cell Mitochondria Supplementation to Oocytes (ASCENT)
D
Dr. SANATHUDAYANGA KANKANAMGAMAGE, PhD
D
Dr. HELARUWAN PASAN KUMARA WA, MD, PhD
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Sunkaky Medical Cooperation
Lead Sponsor
Wish Fertility Hospital Pvt. Ltd
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Sanath Udayanga Kankanam Gamage, Shu Hashimoto, Yuki Miyamoto...
https://pubmed.ncbi.nlm.nih.gov/38777961/Udayanga Sanath Kankanam Gamage, Shu Hashimoto, Yuki Miyamoto...
https://pubmed.ncbi.nlm.nih.gov/35883564/Yoshiharu Morimoto, Udayanga Sanath Kankanam Gamage, Takayuki Yamochi...
https://pubmed.ncbi.nlm.nih.gov/36769061/Sunkaky Medical Cooperation
Lead Sponsor
Wish Fertility Hospital Pvt. Ltd
Collaborating Sponsor