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

Hadassah Medical Center

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Low Ovarian Reserve; Poor Quality Oocytes

Treatments: Procedure: Injection of an autologous mitochondria to the oocyte.

Study type: Interventional

Funder types: Other

Identifiers

NCT01631578

252399- HMO-CTIL

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Injection of mitochondrial concentrate

Experimental group

Description:

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

Treatment:

Procedure: Injection of an autologous mitochondria to the oocyte.

Control

Active Comparator group

Description:

ICSI will be performed conventionally.

Treatment:

Procedure: Injection of an autologous mitochondria to the oocyte.