Clinical Application of Autologous Mitochondria Transplantation for Improving Oocyte Quality.

Overview

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.

Full Title of Study: “A Pilot Study of the Effect of Autologous Mitochondria Transplantation in Assisted Reproductive Technology Clinical Outcome.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2020

Detailed Description

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.

Interventions

  • Procedure: autologous mitochondria transplantation
    • inject autologous mitochondria from bone marrow mesenchymal stem cells into oocyte
  • Combination Product: autologous mitochondria from bone marrow mesenchymal stem cells into oocyte as well as intracytoplasmic sperm injection (ICSI)
    • autologous mitochondria transplantation
  • Drug: intracytoplasmic sperm injection (ICSI)
    • intracytoplasmic sperm injection (ICSI)

Arms, Groups and Cohorts

  • Experimental: autologous mitochondria transplantation
    • inject autologous mitochondria from bone marrow mesenchymal stem cells into oocyte as well as intracytoplasmic sperm injection (ICSI)
  • Active Comparator: ICSI
    • only has intracytoplasmic sperm injection (ICSI)

Clinical Trial Outcome Measures

Primary Measures

  • live birth rate
    • Time Frame: 2-3years
    • number of live birth/ transferred cycle.Compare the live birth rate between the two groups with SPSS 20.0.

Secondary Measures

  • clinical pregnancy rate
    • Time Frame: 2-3years
    • 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.
  • number of oocytes retrieved
    • Time Frame: 2-3years
    • Compare the number of oocytes retrieved between the two group with SPSS 20.0.
  • fertility rate
    • Time Frame: 2-3years
    • Fertility rate(%): number of oocyte fertilized/ number of oocytes retrieved.Compare the fertility rate between the two group with SPSS 20.0.
  • normal fertility rate
    • Time Frame: 2-3years
    • 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.
  • good quality embryo rate
    • Time Frame: 2-3years
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

1. Women age >20 years and <43 years. 2. Anti-müllerian hormone(AMH) level ≥1.1 ng/ml. 3. Previous failed transfer cycle ≥2. 4. BMI>18kg/m2 and <25kg/m2. 5. Written informed consent. Exclusion Criteria:

1. Abnormal uterine development, endometrial adhesion or previous endometrial dysplasia (<7mm) 2. Other medical diseases that cannot be pregnant. 3. Complicated with adenomyosis, endometriosis confirmed by surgery, ovarian endometriosis cyst ≥2 cm by ultrasound, all kind of malignant tumors or precancerous disease. 4. Untreated hydrosalpinx. 5. The man has definite factors that affect the quality of the embryo, such as persistent abnormal DNA fragment rate (>30%) and non-obstructive spermatozoa. 6. Intracytoplasmic sperm injection with donor. Eliminate or falls off Criteria: 1.The number of retrieved oocytes <6.

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 43 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yanhong Deng, doctor – Sun Yat-sen University
  • Overall Contact(s)
    • Xiaoyan Liang, MD. Prof., 020-38048013, lxyzy@263.net

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