Infertility Clinical Trial
Official title:
Autologous Mitochondrial Transfer as a Complementary Technique to ICSI to Improve Oocyte and Embryo Quality in IVF Patients. Pilot Study
The principle objective is to improve embryo quality through autologous micro-injection of
mitochondria isolated from Ovarian stem cells into the oocytes themselves, as a complementary
ICSI technique in patients with low embryo quality in previous IVF cycles and in those who
did not bear children.
This improvement in embryo quality will be determined through on-going pregnancy rate after
treatment and/or improvement in embryo quality according to morphological
(ASEBIR-"Association for the study of Biology in Reproductive Science), morphokinetic
criteria and in Preimplantation Genetic Screening.
Using an adaptive design, retrieved oocytes of approximately 60 patients will be randomized
in the first part of the study to two treatment groups; standard ICSI procedure without
mitochondrial supplementation and ICSI with autologous mitochondrial supplementation.
Following an interim analysis of outcomes, an additional 130 patients may be added, for a
total of 190 patients.
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