Low Ovarian Reserve, Poor Quality Oocytes
Conditions
Keywords
mitochondrial injection
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.
Interventions
PROCEDUREInjection 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.
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oocyte fertilization rate | one day | Fertilization rate is assessed the day following oocyte retrieval. |
| 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). |
Secondary
| Measure | Time frame |
|---|---|
| Clinical pregnancy | within 2 months |
Countries
Israel
Outcome results
None listed