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

NCT ID: NCT01631578

Last Updated: 2015-08-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-08-31

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.

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.

Conditions

Low Ovarian Reserve; Poor Quality Oocytes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Injection of mitochondrial concentrate

A small volume of mitochondrial concentrate will be injected together with the spermatozoon during ICSI.

Group Type: EXPERIMENTAL

Injection of an autologous mitochondria to the oocyte.

Intervention Type: PROCEDURE

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.

Control

ICSI will be performed conventionally.

Group Type: ACTIVE_COMPARATOR

Injection of an autologous mitochondria to the oocyte.

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yoel Shufaro, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hadassah

Locations

Hadassah University Hospital

Jerusalem, , Israel

Countries

Israel

Other Identifiers

252399- HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id