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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Experimental
Other interventionAutologous 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
Trial outcomes
Primary outcomes
Embryo development rate
Analyze and compare the transferable embryo rate per zygote on day 3 \& day 5 between the Intervention and control groups.
Secondary outcomes
Ongoing clinical pregnancy rate after the first transfer
Compare ongoing clinical pregnancy rates between the intervention and conrolgroups
Chemical pregnancy rate
Compare the chemical pregnancy rates between the two groups.
Live Birth rates
Compare live Birth rate following the intervention in both groups
Pregnancy complication
Rate of pregnancy complication in both groups
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