Low Ovarian Reserve Clinical Trial
Official title:
Phase 1 Study of the Impact of Injecting an Autologous Somatic Mitochondrial Concentrate Into Poor Quality Ova.
A prospective randomized controlled trial (RCT) to determine the effect of injecting an autologous somatic mitochondria concentrate, together with the spermatozoon during ICSI, into oocytes of older and or poor prognosis in vitro fertilization (IVF) patients.
Maternal age at first delivery constantly rises in developed countries. Oocyte quality
decreases with advanced age, thus the rate of age-related infertility continuously
increases. Presently oocyte donation is the only prompt solution for this widespread
problem. Deterioration of mitochondrial function was suggested as one of the explanations
for the age-related deterioration of oocyte quality. The supplementation of the ageing
oocyte with autologous mitochondria from dividing somatic cells can be a possible solution
for energetic enrichment, without introducing foreign mtDNA.
We established a non-hazardous clinical grade system to prepare functional autologous
mitochondria concentrate from the granulosa cells aspirated during oocyte pick up. The
mitochondrial preparation was examined and found to be non-toxic. The activity of the
respiratory chain was constant and unaffected by age or ovarian response. Moreover, the
mtDNA in the mitochondrial preparation was found to be intact in all samples examined,
including those from older and low responding patients.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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