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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01631578
First received: May 24, 2012
Last updated: June 28, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Low Ovarian Reserve
Poor Quality Oocytes
Procedure: Injection of an autologous mitochondria to the oocyte.
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of the Impact of Injecting an Autologous Somatic Mitochondrial Concentrate Into Poor Quality Ova.

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Oocyte fertilization rate [ Time Frame: one day ] [ Designated as safety issue: No ]
    Fertilization rate is assessed the day following oocyte retrieval.

  • The rate pace and quality of the early embryonic development [ Time Frame: up to 6 days ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Clinical pregnancy [ Time Frame: within 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631578

Locations
Israel
Hadassah University Hospital
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Yoel Shufaro, MD PhD Hadassah
  More Information

Additional Information:
No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01631578     History of Changes
Other Study ID Numbers: 252399- HMO-CTIL
Study First Received: May 24, 2012
Last Updated: June 28, 2012
Health Authority: Israel:Ministry of Health - Director General

Keywords provided by Hadassah Medical Organization:
mitochondrial injection

ClinicalTrials.gov processed this record on October 01, 2014