Effect of Antioxydant-enriched Media on Blastocyst Euploidy Rates.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-43
SponsorART Fertility Clinics LLC
About this trial
One of the most sensible factors in IVF culture conditions is the susceptibility of gametes and embryos to an induced increase in reactive oxidative species (ROS) caused by the artificial environment. This study aims to evaluate the impact of using antioxidant-supplemented media during culture to evaluate embryo ploidy rates in a prospective randomized trial using sibling oocytes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients undergoing assisted reproductive technology cycles when ICSI is indicated.
Patients when Iin vitto fertilization (IVF) is also performed will be included as far as there are enough oocytes for ICSI randomization. However, IVF oocytes will not be used for the study.
Maternal age 18-43 years old.
PGT-A cycles with only trophectoderm biopsies on day 5/6/7.
Disqualifiers
PGT-M cycles
Fresh and frozen testicular sperm.
Trial design
Design model
Parallel
Treatments tested in this trial
antioxidants-enriched culture medium (Gx)
DrugBlastocyst will be in continuous culture conditions (parallel antioxidants-enriched culture medium (Gx) and Global total one step media (GT) without refreshment on day 3. A refreshment of the media will be done on D5 in both groups.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Group 1: antioxidants-enriched culture medium (Gx)Active comparator 1 intervention
Group B: Group 2: Global total one step media (GT)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Blastocyst ploidy is determined after a biopsy of trophectoderm cells, taken from the blastocyst on day 5, 6 or 7 from development. The following outcomes are possible: • Normal • Abnormal • No result/Inconclusive • Low or high Mosaic
Ploidy rate is calculated by dividing the number of normal embryos by the number of blastocysts biopsied in the group.
Time frame
1 yearSecondary outcomes
1
Cycle ploidy rate: the number of euploid embryos in the group Blastocyst quality at the time of biopsy based on modified Gardner's criteria. Usable blastocyst rate per group and per day of biopsy (day 5, 6, 7)
Ploidy rate is calculated by dividing the number of normal embryos by the number of blastocysts biopsied in the group.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov