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

Low Ovarian Reserve Clinical Trial

Official title:

Phase 1 Study of the Impact of Injecting an Autologous Somatic Mitochondrial Concentrate Into Poor Quality Ova.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01631578
• Other study ID #: 252399- HMO-CTIL
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: May 24, 2012
• Last updated: August 19, 2015
• Start date: January 2012
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel:Ministry of Health - Director General
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Low Ovarian Reserve
• Poor Quality Oocytes

Intervention

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.

Locations

Country	Name	City	State
Israel	Hadassah University Hospital	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oocyte fertilization rate	Fertilization rate is assessed the day following oocyte retrieval.	one day	No
Primary	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	No
Secondary	Clinical pregnancy		within 2 months	No

External Links

•   Article describing preparatory work