Improving the Reproductive Outcome of Poor Quality Ova by Injection of Autologous Somatic Mitochondria

August 19, 2015 updated by: Hadassah Medical Organization

Phase 1 Study of the Impact of Injecting an Autologous Somatic Mitochondrial Concentrate Into Poor Quality Ova.

A prospective randomized controlled trial (RCT) to determine the effect of injecting an autologous somatic mitochondria concentrate, together with the spermatozoon during ICSI, into oocytes of older and or poor prognosis in vitro fertilization (IVF) patients.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Maternal age at first delivery constantly rises in developed countries. Oocyte quality decreases with advanced age, thus the rate of age-related infertility continuously increases. Presently oocyte donation is the only prompt solution for this widespread problem. Deterioration of mitochondrial function was suggested as one of the explanations for the age-related deterioration of oocyte quality. The supplementation of the ageing oocyte with autologous mitochondria from dividing somatic cells can be a possible solution for energetic enrichment, without introducing foreign mtDNA.

We established a non-hazardous clinical grade system to prepare functional autologous mitochondria concentrate from the granulosa cells aspirated during oocyte pick up. The mitochondrial preparation was examined and found to be non-toxic. The activity of the respiratory chain was constant and unaffected by age or ovarian response. Moreover, the mtDNA in the mitochondrial preparation was found to be intact in all samples examined, including those from older and low responding patients.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah University Hospital

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

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Adequate sperm source and uterine cavity. And one or more of the following:
  • Age > 40
  • 3 unsuccessful IVF cycles or
  • > 75% of embryos in previous cycles with > 20-50% fragments or
  • < 50% fertilization rate in previous cycles

Exclusion Criteria:

  • Inadequate sperm source. Inadequate uterine cavity.

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: Injection of mitochondrial concentrate
A small volume of mitochondrial concentrate will be injected together with the spermatozoon during ICSI.
Procedure: Injection of an autologous mitochondria to the oocyte.
In the experimental group an autologous mitochondrial concentrate will be injected together with the sperm during ICSI. In the control group conventional ICSI will be performed.
Active Comparator: Control
ICSI will be performed conventionally.
Procedure: Injection of an autologous mitochondria to the oocyte.
In the experimental group an autologous mitochondrial concentrate will be injected together with the sperm during ICSI. In the control group conventional ICSI will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oocyte fertilization rate
Time Frame: one day
Fertilization rate is assessed the day following oocyte retrieval.
one day
The rate pace and quality of the early embryonic development
Time Frame: up to 6 days
The rate (the proportion of fertilized oocytes developing into embryos), pace of cleavage, and quality (morphological) of the early embryonic development will be assessed during the next 1-6 days (case specific).
up to 6 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy
Time Frame: within 2 months
within 2 months

Collaborators and Investigators

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

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Yoel Shufaro, MD PhD, Hadassah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

January 1, 2012

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

May 24, 2012

First Submitted That Met QC Criteria

June 28, 2012

First Posted (Estimate)

June 29, 2012

Study Record Updates

Last Update Posted (Estimate)

August 20, 2015

Last Update Submitted That Met QC Criteria

August 19, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 252399- HMO-CTIL

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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