Adipose Stem Cell Mitochondria Supplementation to Oocytes (ASCENT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental.
- Who it may be relevant to
- Registry conditions: Female Infertility, Oocyte Competence, Mitochondria, Recurent Implantation Failures. Basic parameters: 29 years — 39 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sri Lanka
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Application of Autologous Adipose Stem Mitochondria Transplantation to Oocytes for Improving Embryo Quality in Patients With Recurrent Pregnancy Failure
Overview
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.
Interventions
- Other Experimental
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).
Primary outcome measures
- Embryo development rate [Time frame: Up to 8 weeks post-intervention]
Secondary outcome measures (8)
- 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]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Sri Lanka · 1 center
- Wish Fertility Hospital Pvt. Ltd — Colombo
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. PMID 35883564
- Kankanam 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. PMID 38777961
- Morimoto 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. PMID 36769061
Identifiers
NCT: NCT07066267 · WishREC/24-011