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

NCT01631578 | Withdrawn Phase 1

• 1 other identifier: 252399- HMO-CTIL
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Ovarian Reserve; Poor Quality Oocytes

Keywords

mitochondrial injection

Outcome Measures

Primary Outcomes (2)

• Oocyte fertilization rate

  Fertilization rate is assessed the day following oocyte retrieval.

  one day

• The rate pace and quality of the early embryonic development

  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 Outcomes (1)

• Clinical pregnancy

  within 2 months

Study Arms (2)

Injection of mitochondrial concentrate

EXPERIMENTAL

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

Procedure: Injection of an autologous mitochondria to the oocyte.

Control

ACTIVE COMPARATOR

ICSI will be performed conventionally.

Procedure: Injection of an autologous mitochondria to the oocyte.

Interventions

Injection of an autologous mitochondria to the oocyte. 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; Injection of mitochondrial concentrate

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Inadequate sperm source. Inadequate uterine cavity.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah University Hospital

Jerusalem, Israel

Location

Study Officials

• Yoel Shufaro, MD PhD

  Hadassah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: June 29, 2012
• Study Start: January 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 20, 2015

Record last verified: 2015-08

Locations

IL (1)