Autologous Mitochondrial Transfer in ICSI to Improve Oocyte and Embryo Quality in IVF Patients. Pilot Study
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|ClinicalTrials.gov Identifier: NCT02586298|
Recruitment Status : Completed
First Posted : October 26, 2015
Last Update Posted : August 23, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Other: Autologous mitochondria with ICSI Other: STANDARD ICSI PROCEDURE||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Autologous Mitochondrial Transfer as a Complementary Technique to ICSI to Improve Oocyte and Embryo Quality in IVF Patients. Pilot Study|
|Actual Study Start Date :||October 2015|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||July 2017|
Experimental: ICSI with mitochondria
Half of the Metaphase II oocytes retrieved after the controlled ovarian stimulation will be randomized to this group and autologous mitochondria from the patient's ovarian cortex will be introduced into the oocyte during the intracytoplasmic sperm injection in the vitro fertilization treatment.
Other: Autologous mitochondria with ICSI
Autologous mitochondria during the intracytoplasmic sperm injection (ICSI) process will be added to this randomized group of oocytes.
Active Comparator: Control ICSI without mitochondria
The other half of the metaphase II oocytes retrieved after the controlled ovarian stimulation will be randomized to this group and will not receive autologous mitochondria during the intracytoplasmic sperm injection (ICSI) in the vitro fertilization treatment. Control Group
Other: STANDARD ICSI PROCEDURE
STANDARD ICSI PROCEDURE
- Rate of ongoing pregnancy [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02586298
|Valencia, Spain, 46015|
|Study Director:||Elena Labarta, MD PhD||Gynecologist Specialist TRA, IVI Valencia|
|Principal Investigator:||Antonio Pellicer, MD PhD||Gynecologist specialist TRA, President IVI Valencia|