Actively Recruiting
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 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
Brief Title
Adipose Stem Cell Mitochondria Supplementation to Oocytes (ASCENT)
Who Can Participate
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
Research Team
D
Dr. SANATHUDAYANGA KANKANAMGAMAGE, PhD
D
Dr. HELARUWAN PASAN KUMARA WA, MD, PhD
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