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

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ClinicalTrials.gov Identifier: NCT01631578
Recruitment Status : Withdrawn (PI moved from medical center)
First Posted : June 29, 2012
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Low Ovarian Reserve Poor Quality Oocytes Procedure: Injection of an autologous mitochondria to the oocyte. Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of the Impact of Injecting an Autologous Somatic Mitochondrial Concentrate Into Poor Quality Ova.
Study Start Date : January 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Oocyte fertilization rate [ Time Frame: one day ]
    Fertilization rate is assessed the day following oocyte retrieval.

  2. 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).


Secondary Outcome Measures :
  1. Clinical pregnancy [ Time Frame: within 2 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631578


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

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Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01631578    
Other Study ID Numbers: 252399- HMO-CTIL
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: August 20, 2015
Last Verified: August 2015
Keywords provided by Hadassah Medical Organization:
mitochondrial injection