Autologous Mitochondrial Transfer as a Complementary Technique to ICSI to Improve Oocyte and Embryo Quality in IVF Patients. Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infertility
- Sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Rate of ongoing pregnancy
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The principle objective is to improve embryo quality through autologous micro-injection of mitochondria isolated from Ovarian stem cells into the oocytes themselves, as a complementary ICSI technique in patients with low embryo quality in previous IVF cycles and in those who did not bear children.
This improvement in embryo quality will be determined through on-going pregnancy rate after treatment and/or improvement in embryo quality according to morphological (ASEBIR-"Association for the study of Biology in Reproductive Science), morphokinetic criteria and in Preimplantation Genetic Screening.
Using an adaptive design, retrieved oocytes of approximately 60 patients will be randomized in the first part of the study to two treatment groups; standard ICSI procedure without mitochondrial supplementation and ICSI with autologous mitochondrial supplementation. Following an interim analysis of outcomes, an additional 130 patients may be added, for a total of 190 patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patients must have read, understood and signed the ICF.
- •Age ≤ 42 years.
- •Serum AMH ≥ 4 pM/L.
- •Previous IVF cycle with 5 or more metaphase II oocytes after retrieval
- •Will undergo an IVF cycle with arrays in Preimplantation Genetic Screening.
- •Semen sample with concentrations exceeding 3 million/mL progressive motile sperm.
- •Present with a history of at least one previous cycle of IVF with embryo transfer and no pregnancy due to low embryo quality. Low embryo quality is understood as \> 70% of the embryos obtained being included in the worst prognosis category according to any of the following criteria:
- •Low or abnormal Fertilization Rate despite semen count \> 3 million/mL.
- •Deficient quality embryos according to morphological criteria established by ASEBIR:
- •i. Embryo D2 and D3: classified as Type C or Type D according to ASEBIR criteria.
Exclusion Criteria
- •Formal contraindication for ovarian cortex biopsy or follicle puncture.
- •Severe male factor (concentration\<3 million/mL of progressive motile sperm).
- •Any characteristic incompatible with carrying out a new IVF cycle at IVI Valencia.
Outcomes
Primary Outcomes
Rate of ongoing pregnancy
Time Frame: 12 weeks