Adipose Stem Cell Mitochondria Supplementation to Oocytes (ASCENT)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age29-39
SponsorSunkaky Medical Cooperation

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental

    Other intervention

    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).

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Autologous Mitochondria transferActive comparator 1 intervention
Group B: Conventonal Intracytoplasmic Sperm InjectionNo intervention 0 interventions

Trial outcomes

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.

Time frame
Up to 8 weeks post-intervention

Secondary outcomes

1

Ongoing clinical pregnancy rate after the first transfer

Compare ongoing clinical pregnancy rates between the intervention and conrolgroups

Time frame
Up to 18 months post-intervention
2

Chemical pregnancy rate

Compare the chemical pregnancy rates between the two groups.

Time frame
Up to 18 months post-intervention
3

Live Birth rates

Compare live Birth rate following the intervention in both groups

Time frame
Up to 24 months post-intervention
4

Pregnancy complication

Rate of pregnancy complication in both groups

Time frame
Up to 24 months post-intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sunkaky Medical Cooperation

Lead sponsor

Wish Fertility Hospital Pvt. Ltd

Collaborator