NCT03639506

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

2.3 years

First QC Date

August 17, 2018

Last Update Submit

August 20, 2018

Conditions

Repetition Failure

Keywords

repetition failureautologous mitochondria transplantationembryo qualitylive birth rate

Outcome Measures

Primary Outcomes (1)

  • live birth rate

    number of live birth/ transferred cycle.Compare the live birth rate between the two groups with SPSS 20.0.

    2-3years

Secondary Outcomes (5)

  • clinical pregnancy rate

    2-3years

  • number of oocytes retrieved

    2-3years

  • fertility rate

    2-3years

  • normal fertility rate

    2-3years

  • good quality embryo rate

    2-3years

Study Arms (2)

autologous mitochondria transplantation

EXPERIMENTAL

inject autologous mitochondria from bone marrow mesenchymal stem cells into oocyte as well as intracytoplasmic sperm injection (ICSI)

Procedure: autologous mitochondria transplantationCombination Product: autologous mitochondria from bone marrow mesenchymal stem cells into oocyte as well as intracytoplasmic sperm injection (ICSI)

ICSI

ACTIVE COMPARATOR

only has intracytoplasmic sperm injection (ICSI)

Drug: intracytoplasmic sperm injection (ICSI)

Interventions

autologous mitochondria transplantationPROCEDURE

inject autologous mitochondria from bone marrow mesenchymal stem cells into oocyte

autologous mitochondria transplantation
autologous mitochondria from bone marrow mesenchymal stem cells into oocyte as well as intracytoplasmic sperm injection (ICSI)COMBINATION_PRODUCT

autologous mitochondria transplantation

autologous mitochondria transplantation
intracytoplasmic sperm injection (ICSI)DRUG

intracytoplasmic sperm injection (ICSI)

ICSI

Eligibility Criteria

Age20 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women age \>20 years and \<43 years.
  • Anti-müllerian hormone（AMH） level ≥1.1 ng/ml.
  • Previous failed transfer cycle ≥2.
  • BMI\>18kg/m2 and \<25kg/m2.
  • Written informed consent.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Sperm Injections, Intracytoplasmic

Intervention Hierarchy (Ancestors)

Fertilization in VitroReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Central Study Contacts

Xiaoyan Liang, MD. Prof.

CONTACT

020-38048013lxyzy@263.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

August 17, 2018

First Posted

August 21, 2018

Study Start

September 1, 2018

Primary Completion

December 1, 2020

Study Completion

September 1, 2021

Last Updated

August 21, 2018

Record last verified: 2018-08