Actively Recruiting

Phase Not Applicable
Age: 29Years - 39Years
FEMALE
NCT07066267

Adipose Stem Cell Mitochondria Supplementation to Oocytes (ASCENT)

Led by Sunkaky Medical Cooperation · Updated on 2025-07-17

20

Participants Needed

1

Research Sites

87 weeks

Total Duration

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Sponsors

S

Sunkaky Medical Cooperation

Lead Sponsor

W

Wish Fertility Hospital Pvt. Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Adipose Stem Cell Mitochondria Supplementation to Oocytes (ASCENT)

Who Can Participate

Age: 29Years - 39Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Having at least three previous failed IVF trials
  • Consent to collect biopsies for Preimplantation Genetic Testing for Aneuploidy (PGTA) analysis
  • Consent to have single blastocyst transfer (recommended)
  • No major uterine or ovarian abnormalities
  • Consent to have all embryos frozen
  • Consent to collect adipose tissue via subcutaneous liposuction
  • Body mass index (BMI) less than 26 kg/m2
Not Eligible

You will not qualify if you...

  • Ovarian endometriosis with Chocolate cysts classified as American Fertility Society (AFS) type 3 or 4
  • Medical contraindications to oocyte retrieval or related procedures
  • Ovarian hyperstimulation syndrome
  • Bleeding disorders
  • Sex hormone allergies
  • Severe emotional disorders affecting injections
  • Severe sperm abnormalities
  • Motile sperm count less than 5 million per mL
  • Uterine structural anomalies
  • Polycystic ovaries
  • Premature ovarian failure

AI-Screening

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Trial Site Locations

Total: 1 location

1

Wish Fertility Hospital Pvt. Ltd

Colombo, Sri Lanka

Actively Recruiting

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Research Team

D

Dr. SANATHUDAYANGA KANKANAMGAMAGE, PhD

CONTACT

D

Dr. HELARUWAN PASAN KUMARA WA, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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