Adipose Stem Cell Mitochondria Supplementation to Oocytes (ASCENT)

Last updated: July 14, 2025
Sponsor: Sunkaky Medical Cooperation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hypogonadism

Infertility

Treatment

Experimental

Clinical Study ID

NCT07066267
WishREC/24-011
  • Ages 29-39
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Having at least three previous failed IVF trial

  • Specifically consented for to collect biopsies for Preimplantation generic testingfor 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

Exclusion Criteria:

  • Ovarian endometriosis with Chocolate cysts (American Fertility Society (AFS))classification type 3 and 4

  • Any medical contraindication oocyte retrieval or subsequent procedures Ovarianhyperstimulation syndrome Bleeding disorders Sex hormone allergies Severe emotionaldefect on injections

  • Severe sperm abnormalities

  • <5 million/mL motile sperm

  • Uterine structural anomalies

  • Polycystic ovaries

  • Premature ovarian failure

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Experimental
Phase:
Study Start date:
April 25, 2025
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Wish Fertility Hospital Pvt. Ltd

    Colombo,
    Sri Lanka

    Active - Recruiting

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