Clinical Application of Autologous Mitochondria Transplantation for Improving Oocyte Quality.

August 20, 2018 updated by: Yanhong Deng, Sun Yat-sen University

A Pilot Study of the Effect of Autologous Mitochondria Transplantation in Assisted Reproductive Technology Clinical Outcome.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: autologous mitochondria transplantation
inject autologous mitochondria from bone marrow mesenchymal stem cells into oocyte as well as intracytoplasmic sperm injection (ICSI)
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
Active Comparator: ICSI
only has intracytoplasmic sperm injection (ICSI)
Drug: intracytoplasmic sperm injection (ICSI)
intracytoplasmic sperm injection (ICSI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2-3years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2-3years
number of oocytes retrieved
Time Frame: 2-3years
Compare the number of oocytes retrieved between the two group with SPSS 20.0.
2-3years
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.
2-3years
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.
2-3years
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.
2-3years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2018

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

August 17, 2018

First Submitted That Met QC Criteria

August 20, 2018

First Posted (Actual)

August 21, 2018

Study Record Updates

Last Update Posted (Actual)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • newivf20180817

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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