Embryo quality was ranked as one of the most important predictors in determining the success of implantation, while clinically some patients may experience repeated IVF failure due to persistent poor embryo quality.Mitochondria, as the energy factory, is confirmed being a hallmark of quality and developmental potential of human oocytes, and decreased mitochondria copy number was reported to be associated with oocyte aging and dysfunctional mitochondria would be expected to influence the late stages of oocyte maturation and early embryogenesis.The objective of this study is to evaluate the effect of mitochondria transfer from bone marrow mesenchymal stem cell on the quality of oocyte.
This study is a pilot study to investigate the effect of autologous mitochondria transplantation for improving oocyte quality. Design: randomized controlled trial. Setting: Assisted reproductive technologies unit. Patients: patients who is in accordance with the inclusion criteria, and not meet the exclusion criteria, who had repeated IVF treatment from Sep 2018 to Sep 2021. Intervention: The comparison was made between mitochondria transfer(MIT) group and the control group, both groups are conducted with the GnRH-a super-long protocol for IVF treatment. MIT group injects autologous mitochondria from bone mesenchymal stem cells into oocyte. Main outcome measures: The primary outcome of the study is live birth rate. The secondary outcomes were clinical pregnancy rate, number of oocytes retrieved, fertility rate, normal fertilization rate, rate of transferable embryo and good quality embryo rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
inject autologous mitochondria from bone marrow mesenchymal stem cells into oocyte
autologous mitochondria transplantation
intracytoplasmic sperm injection (ICSI)
live birth rate
number of live birth/ transferred cycle.Compare the live birth rate between the two groups with SPSS 20.0.
Time frame: 2-3years
clinical pregnancy rate
Clinical pregnancy means pregnancy sac is seen intrauterine under ultrasound 7 weeks after embryo transferred. Clinical pregnancy rate(%): number of clinical pregnancy/transferred cycle.Compare the clinical pregnancy rate between the two group with SPSS 20.0.
Time frame: 2-3years
number of oocytes retrieved
Compare the number of oocytes retrieved between the two group with SPSS 20.0.
Time frame: 2-3years
fertility rate
Fertility rate(%): number of oocyte fertilized/ number of oocytes retrieved.Compare the fertility rate between the two group with SPSS 20.0.
Time frame: 2-3years
normal fertility rate
Normal fertility rate(%): number of oocyte normally fertilized/ number of oocytes retrieved. Compare the normal fertility rate between the two group with SPSS 20.0.
Time frame: 2-3years
good quality embryo rate
Cleavage embryo grades 1 or 2 with 6-10 blastomeres were considered good quality embryos. Good quality embryo rate(%): number of good quality embryo/number of fertilized oocytes.Compare the good quality embryo rate between the two group with SPSS 20.0.
Time frame: 2-3years
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