An interventional study of Experimental in Female Infertility, Oocyte Competence and Mitochondria, sponsored by Sunkaky Medical Cooperation. Recruiting at 1 site in Sri Lanka. Open to female participants aged 29 Years to 39 Years. Per ClinicalTrials.gov, last updated 2025-07-17.
Sponsored by Sunkaky Medical Cooperation · Not applicable, Interventional, and Treatment
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.
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.
540 studies on the registry are indexed under Infertility, Female; 138 are open to participants now.
This study's planned enrollment of 20 is below the median of 100 across 371 interventional studies indexed under Infertility, Female.
Browse Infertility, Female studies →Sunkaky Medical Cooperation is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Mitochondria isolated from autologous adipose-derived stem cells are transplanted into the oocyte in conjunction with intracytoplasmic sperm injection (ICSI); Mito-ICSI group
Other: Experimental
Conventional ICSI; Control group
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).
Embryo development rate
Analyze and compare the transferable embryo rate per zygote on day 3 \& day 5 between the Intervention and control groups.
Time frame: Up to 8 weeks post-intervention
Ongoing clinical pregnancy rate after the first transfer
Compare ongoing clinical pregnancy rates between the intervention and conrolgroups
Time frame: Up to 18 months post-intervention
Chemical pregnancy rate
Compare the chemical pregnancy rates between the two groups.
Time frame: Up to 18 months post-intervention
Live Birth rates
Compare live Birth rate following the intervention in both groups
Time frame: Up to 24 months post-intervention
Pregnancy complication
Rate of pregnancy complication in both groups
Time frame: Up to 24 months post-intervention
Abortion rate
Compare the abortion rates in both groups
Time frame: Up to 24 months post-intervention
Additional in vitro fertilization - outcome indicators
Compare the rate of fertilization in between two groups
Time frame: Up to 8 weeks post-intervention
Additional in vitro fertilization - outcome indicators
Rate of abnormal fertilization in both groups
Time frame: Up to 8 weeks post-intervention
Additional in vitro fertilization - outcome indicators
The rate of non-transferable embryos in both groups
Time frame: Up to 8 weeks post-intervention
Plan to share: No — Undecided
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Sunkaky Medical Cooperation