Adipose Stem Cell Mitochondria Supplementation to Oocytes (ASCENT)

Sunkaky Medical Cooperation

Status: Enrolling

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

Treatments: Other: Experimental

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07066267

WishREC/24-011

Details and patient eligibility

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 29 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Autologous Mitochondria transfer

Active Comparator group

Description:

Mitochondria isolated from autologous adipose-derived stem cells are transplanted into the oocyte in conjunction with intracytoplasmic sperm injection (ICSI); Mito-ICSI group

Treatment:

Other: Experimental

Conventonal Intracytoplasmic Sperm Injection

No Intervention group

Description:

Conventional ICSI; Control group