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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Low Ovarian Reserve, Poor Quality Oocytes

Intervention / Treatment
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* Procedure: Injection of an autologous mitochondria to the oocyte.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injection of mitochondrial concentrate<br>A small volume of mitochondrial concentrate will be injected together with the spermatozoon during ICSI. | Procedure: Injection of an autologous mitochondria to the oocyte.<br>* 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.<br>|
| Active Comparator: Control<br>ICSI will be performed conventionally. | Procedure: Injection of an autologous mitochondria to the oocyte.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy |  | within 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mitochondrial injection