Adipose Stem Cell Mitochondria Supplementation to Oocytes (ASCENT)

NCT07066267 | Recruiting DMC

• 1 other identifier: WishREC/24-011
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Female Infertility; Oocyte Competence; Mitochondria; Recurent Implantation Failures; Advanced Age

Keywords

mitochondria; mitochondria transplantation; Adipose stem cell; oocyte; Female infertility

Outcome Measures

Primary Outcomes (1)

• Embryo development rate

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

  Up to 8 weeks post-intervention

Secondary Outcomes (8)

• Ongoing clinical pregnancy rate after the first transfer

  Up to 18 months post-intervention

• Chemical pregnancy rate

  Up to 18 months post-intervention

• Live Birth rates

  Up to 24 months post-intervention

• Pregnancy complication

  Up to 24 months post-intervention

• Abortion rate

  Up to 24 months post-intervention

Study Arms (2)

Autologous Mitochondria transfer

ACTIVE COMPARATOR

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

Conventonal Intracytoplasmic Sperm Injection

NO INTERVENTION

Conventional ICSI; Control group

Interventions

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).

Autologous Mitochondria transfer

Eligibility Criteria

• Age: 29 Years - 39 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunkaky Medical Cooperation: lead
• Wish Fertility Hospital Pvt. Ltd: collaborator

Study Sites (1)

Wish Fertility Hospital Pvt. Ltd

Colombo, Sri Lanka

RECRUITING

Related Publications (3)

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Dr. Helaruwan Pasan Kumara WA, MD, PhD

  Wish Fertility Hospital Pvt. Ltd

  PRINCIPAL INVESTIGATOR

• Prof. Yoshiharu Morimoto, MD, PhD

  Horac Grand Front Osaka Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. SANATHUDAYANGA KANKANAMGAMAGE, PhD

CONTACT

+818014361766; udayanga646@ivfjapan.com

Dr. HELARUWAN PASAN KUMARA WA, MD, PhD

CONTACT

+94 77 327 3866, +9477 478 878; helaruwanpasankumara@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a triple-blind (Patient, Embryologist, Doctor), single-center, randomized, controlled experimental pilot study.

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 15, 2025
• Study Start: April 25, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SR (1)