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

Phase 1

Withdrawn

• Conditions: Low Ovarian Reserve; Poor Quality Oocytes
• Interventions: Procedure: Injection of an autologous mitochondria to the oocyte.

• Registration Number: NCT01631578
• Lead Sponsor: Hadassah Medical Organization

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-05-24
• Study First Submitted QC: 2012-06-28
• Study First Posted: 2012-06-29
• Status Verified: 2015-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-19
• Last Update Posted: 2015-08-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Injection of mitochondrial concentrate	Injection of an autologous mitochondria to the oocyte.	A small volume of mitochondrial concentrate will be injected together with the spermatozoon during ICSI.
Control	Injection of an autologous mitochondria to the oocyte.	ICSI will be performed conventionally.

Primary Outcome Measures

Name	Time	Method
The rate pace and quality of the early embryonic development	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).
Oocyte fertilization rate	one day	Fertilization rate is assessed the day following oocyte retrieval.

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy	within 2 months

Trial Locations

Locations (1)

Hadassah University Hospital; 🇮🇱 Jerusalem, Israel