An interventional study of Maternal spindle transfer in Pearson Syndrome and Mitochondria DNA Deletion, sponsored by Taipei Fertility Center. Enrolling by invitation at 1 site in Taiwan. Open to female participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Taipei Fertility Center · Not applicable, Interventional, and Treatment
Mitochondria are important organelles that generate energy (ATP) in human and mammalian cells. Currently, there are more than 50 kinds of diseases known to be related to mitochondrial defects in Taiwan. The incidence of mitochondrial diseases is very rare, about 1/5,000 to 1/10,000. The abundancy of mitochondria riches to 100,000 DNA copies in one oocyte, and the threshold of DNA mutation rate to cause pathogenicity is usually greater than 70%. Since mitochondria are inherited maternally, the pathogenic mitochondrial DNA in oocytes could be removed by modern artificial reproductive technology (ART). By treating with mitochondria replacement therapy (MRT), here we use the spindle transfer, following artificial insemination, the ooplasm from healthy donor oocytes could be transferred into the oocytes of patients to remove defected mitochondria, therefore creating the opportunity to produce healthy offspring. Therefore, in order to further detect the carrying rate of mutated mitochondrial genes in patients with mitochondrial defects after MRT, we aim to detect the mitochondria mutation in germ cells of patients in order to improve the specificity and operation procedures of this therapy.
Three cases with mitochondria disease and three healthy donor will be enrolled for MRT. The following specimens are expected to be collected in this study: (1) cumulus cells that surrounded the oocyte during egg retrieval, (2) clinically discarded ooplasm of donor oocytes harvested during MRT (3) the patient's own ooplasm, and (4) blastocyst trophectoderm (TE) biopsy completed by MRT. Those specimens will be sequenced to verify whether the mitochondrial DNA from donor is normal, and cross-comparison with the non-developed embryos after the MRT for improvement of heteroplasmy of mitochondrial DNA. Our study will establish the examination method to prevent the possibility of disease carried donating eggs with uncertain background accurately, and it helps to increase the precision and clinical applicability of MRT.
26 studies on the registry are indexed under VLCAD deficiency; 6 are open to participants now.
This study's planned enrollment of 6 is below the median of 13 across 15 interventional studies indexed under VLCAD deficiency.
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The human immunodeficiency virus, which weakens the immune system.
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single arm study. Percipitants with previous delivered child or fetus with mitochondria defects, will accept the intervention of mitochondria replacement therapy (MRT) during IVF cycle.
Procedure: Maternal spindle transfer
Using maternal spindle transfer technique to replace diseased ooplasm with healthy donor eggs.
Mitochondria DNA heterogeneity
Measurement of heteroplasmy of mitochondria DNA in TE biopsied D5/D6 embryos.
Time frame: Chromosome euploidy and mitochondria heteroplasmy after 3 months after embryo biopsy.
Obstetric outcome after embryo transfer
Embryos with low carryover will be transfered and obstetric outcome will be recorded.
Time frame: Pregnancy outcome will be recorded after14th day for hCG examination. Gestational sac will be observed on 28 days after embryo transfer. Chromosome ploidy and mithchondria DNA heteroplasmy will be analyzed by amniocentesis
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