NCT05919186

Effects of Antioxidant Supplementation of Culture Media on IVF Embryos

Impact of Repeated Antioxidant Supplementation of Embryo Culture Media on Blastocyst Utilization and Expansion Rate Under Two Different O2 Concentrations

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 293 (actual)
• Sponsor: Liliana Berenice Ramírez Domínguez · Industry
• Sex: Female
• Age: 18 Years – 37 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to investigate the impact of repeated antioxidant supplementation on blastocyst utilization and expansion rates in embryos under different oxygen concentrations. The study aims to answer the following main questions: * Does adding antioxidants every 12 hours to embryo culture media improve usable and expanded blastocyst utilization rates on days 5 and 6? * How are the O2 concentrations related to the effect of different methods of antioxidants supplementation on blastocysts utilization and expansion rates? Participants in this study are infertile couples undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycles. * Zygotes will be incubated at either 5% or 20% oxygen tension until the blastocyst stage. * Sibling zygotes will be divided into four groups: Group 1A and 1B: Antioxidants every 12 hours at either 5% or 20% O2 tension, respectively. Group 2A and 2B: Antioxidants only once at the beginning of embryo culture at either 5% or 20% O2 tension, respectively. Researchers will compare the four groups to determine if the repeated antioxidant supplementation of the culture media leads to improved blastocyst utilization and expansion rates compared to the baseline group.

Detailed description

This study is focused on the role of antioxidants (AOXs) in mitigating reactive oxygen species and oxidative stress, which have been associated with failure in in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI). The research aimed to evaluate the effect of two different methods of antioxidants supplementation at two O2 tensions on blastocyst utilization and expansion rates. To achieve this, 3603 zygotes from infertile couples undergoing IVF or ICSI were included in the study. The zygotes were divided into two groups: Group 1A and 1B: Antioxidants every 12 hours at either 5% or 20% O2 tension, respectively. Group 2A and 2B: Antioxidants only once at the beginning of embryo culture at either 5% or 20% O2 tension, respectively. .

Conditions

• Infertility, Female
• Infertility, Male

Interventions

Type	Name	Description
DRUG	EmbryORP®	EmbryORP® is a novel antioxidant (Cystein 32.9 mM, Glutation 32.6 mM, Ascorbic Acid 22.7 mM)
DEVICE	O2 tension 20%	After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2, and 95%
DEVICE	O2 tension 5%	After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2 and 95%

Timeline

• Start date: 2021-10-12
• Primary completion: 2022-04-12
• Completion: 2022-05-10
• First posted: 2023-06-26
• Last updated: 2023-06-26

Locations

1 site across 1 country: Mexico