Advanced Age, Female Infertility, Mitochondria, Oocyte Competence, Recurent Implantation Failures
Conditions
Keywords
mitochondria, mitochondria transplantation, Adipose stem cell, oocyte, Female infertility
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.
Detailed 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.
Interventions
OTHERExperimental
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).
Sponsors
Wish Fertility Hospital Pvt. Ltd
Sunkaky Medical Cooperation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Intervention model description
This is a triple-blind (Patient, Embryologist, Doctor), single-center, randomized, controlled experimental pilot study.
Eligibility
Sex/Gender
FEMALE
Age
29 Years to 39 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Embryo development rate | Up to 8 weeks post-intervention | Analyze and compare the transferable embryo rate per zygote on day 3 & day 5 between the Intervention and control groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chemical pregnancy rate | Up to 18 months post-intervention | Compare the chemical pregnancy rates between the two groups. |
| Live Birth rates | Up to 24 months post-intervention | Compare live Birth rate following the intervention in both groups |
| Ongoing clinical pregnancy rate after the first transfer | Up to 18 months post-intervention | Compare ongoing clinical pregnancy rates between the intervention and conrolgroups |
| Abortion rate | Up to 24 months post-intervention | Compare the abortion rates in both groups |
| Additional in vitro fertilization - outcome indicators | Up to 8 weeks post-intervention | Compare the rate of fertilization in between two groups |
| Pregnancy complication | Up to 24 months post-intervention | Rate of pregnancy complication in both groups |
Countries
Sri Lanka
Contacts
Primary ContactDr. SANATHUDAYANGA KANKANAMGAMAGE, PhD
Backup ContactDr. HELARUWAN PASAN KUMARA WA, MD, PhD
Outcome results
None listed