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NCT Number: NCT07066267

Adipose Stem Cell Mitochondria Supplementation to Oocytes (ASCENT)

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.

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Key information

Conditions

Female Infertility Advanced Age Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Mitochondria Oocyte Competence Recurent Implantation Failures Urogenital Diseases

Age range

29 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wish Fertility Hospital Pvt. Ltd

Colombo, Sri Lanka

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental

Other

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 outcomes

  1. Embryo development rate

    Time frame: Up to 8 weeks post-intervention

    Analyze and compare the transferable embryo rate per zygote on day 3 & day 5 between the Intervention and control groups.

Secondary outcomes

  1. Ongoing clinical pregnancy rate after the first transfer

    Time frame: Up to 18 months post-intervention

    Compare ongoing clinical pregnancy rates between the intervention and conrolgroups

  2. Chemical pregnancy rate

    Time frame: Up to 18 months post-intervention

    Compare the chemical pregnancy rates between the two groups.

  3. Live Birth rates

    Time frame: Up to 24 months post-intervention

    Compare live Birth rate following the intervention in both groups

  4. Pregnancy complication

    Time frame: Up to 24 months post-intervention

    Rate of pregnancy complication in both groups

  5. Abortion rate

    Time frame: Up to 24 months post-intervention

    Compare the abortion rates in both groups

  6. Additional in vitro fertilization - outcome indicators

    Time frame: Up to 8 weeks post-intervention

    Compare the rate of fertilization in between two groups

  7. Additional in vitro fertilization - outcome indicators

    Time frame: Up to 8 weeks post-intervention

    Rate of abnormal fertilization in both groups

  8. Additional in vitro fertilization - outcome indicators

    Time frame: Up to 8 weeks post-intervention

    The rate of non-transferable embryos in both groups

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. HELARUWAN PASAN KUMARA WA, MD, PhD

CONTACT

[email protected]

+94 77 327 3866, +9477 478 878

Dr. SANATHUDAYANGA KANKANAMGAMAGE, PhD

CONTACT

[email protected]

+818014361766

Sponsors and collaborators

Lead sponsor

Sunkaky Medical Cooperation

Industry

Collaborators

  • Wish Fertility Hospital Pvt. Ltd

Registry information

Official study title

Clinical Application of Autologous Adipose Stem Mitochondria Transplantation to Oocytes for Improving Embryo Quality in Patients With Recurrent Pregnancy Failure

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 15, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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