Effects of Antioxidant Supplementation of Culture Media on IVF Embryos
Condition: Infertility, Female; Infertility, Male
MeSH terms: Infertility; Infertility, Female; Infertility, Male
Study type: Interventional

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.

      .
    

Intervention name(s): EmbryORP®; O2 tension 20%; O2 tension 5%
Intervention type(s): Drug; Device; Device
Intervention description(s): EmbryORP® is a novel antioxidant (Cystein 32.9 mM, Glutation 32.6 mM, Ascorbic Acid 22.7 mM); After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2, and 95%; After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2 and 95%
Other intervention name(s): EmbryORP
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The data registry utilized internal and external measures to ensure accuracy. SOPs were developed for registry operations and data analysis. Data were recorded in clinical records and clinic-specific databases. Regular backups and monthly audits were conducted to safeguard data and verify accuracy. External audits occurred every 6 months. Access controls protected privacy. Appropriate statistical techniques and sample size assessment were used for data analysis. A study on embryo development analyzed 3603 zygotes, assessing blastocyst outcomes and detailing procedures for ovarian stimulation, retrieval, sperm preparation, and assisted reproduction techniques. These measures ensured accurate and reliable results.
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Blastocyst Rate; IVF; Embryo Culture; Antioxidants