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Clinical trial

Antioxidants-enriched Single-step vs Global Total Single-step Embryo Culture Media: Effect on Blastocyst Euploidy Rates.

ID
Name
2312-ABU-028-VF
Description
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.
Trial arms
Trial start
2024-03-01
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Not yet recruiting
Treatment
antioxidants-enriched culture medium (Gx)
Blastocyst 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.
Arms:
Group 1: antioxidants-enriched culture medium (Gx), Group 2: Global total one step media (GT)
Other names:
Global total one step media (GT)
Size
500
Primary endpoint
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
1 year
Eligibility criteria
Inclusion Criteria: * 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. * Patients with more than 6 COCs expected for ICSI. * Body mass index \<35. * Fresh and frozen ejaculated sperm. Exclusion Criteria: * PGT-M cycles * Fresh and frozen testicular sperm.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomization list (indicating Gx Media Vitrolife or GT Coopersurgical) will be used to verify to which group the first half of oocytes will be allocated to. In case an odd number of oocytes is present, one extra oocyte is allocated to the group as indicated by the randomization list.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 500, 'type': 'ESTIMATED'}}
Updated at
2024-02-15

1 organization

1 product

2 indications

Organization
ART Fertility Clinics
Product
Antioxidants-Enriched Culture Medium
Indication
infertility
Indication
In Vitro Fertilization