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Completed

NCT Number: NCT05919186

Effects of Antioxidant Supplementation of Culture Media on IVF Embryos

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.

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

18 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CITMER

Mexico City, 11520, Mexico

About this study

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.

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infertile women with from 18 to 37 years old at the moment of oocyte collection, tubal factor, polycystic ovary syndrome, uterine factor, or unexplained infertility.
  • More than 2 oocytes by conventional in vitro fertilization (cIVF) and intracytoplasmic sperm injection (ICSI).

Exclusion criteria

  • Infertile woman in assisted reproduction treatment with less than 2 oocytes collected.
  • Infertile woman in assisted reproduction treatment with less than 2 oocytes fertilized by conventional in vitro fertilization (cIVF) and intracytoplasmic sperm injection (ICSI)

Treatment and study plan

EmbryORP®

Drug

EmbryORP® is a novel antioxidant (Cystein 32.9 mM, Glutation 32.6 mM, Ascorbic Acid 22.7 mM)

Other names: EmbryORP

O2 tension 20%

Device

After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2, and 95%

O2 tension 5%

Device

After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2 and 95%

Primary outcomes

  1. Rate of usable blastocysts on day 5

    Time frame: 5 days

    Usable blastocysts were defined as vitrified, transferred, and/or biopsied blastocysts at day 5

  2. Rate of expanded blastocysts on day 5

    Time frame: 5 days

    Expanded blastocysts were defined as usable blastocysts with a 4 to 6 expansion grade at day 5

  3. Rate of sable blastocysts on day 6

    Time frame: 6 days

    Usable blastocysts were defined as vitrified, transferred, and/or biopsied blastocysts at day 6

  4. Rate of expanded blastocysts on day 6

    Time frame: 6 days

    Expanded blastocysts were defined as usable blastocysts with a 4 to 6 expansion grade at day 6

  5. Rate of acumulative usable blastocysts

    Time frame: 5 - 6 days

    Usable blastocysts were defined as vitrified, transferred, and/or biopsied blastocysts at days 5 and 6

  6. Rate of acumulative expanded blastocysts.

    Time frame: 5 - 6 days

    Expanded blastocysts were defined as usable blastocysts with a 4 to 6 expansion grade at days 5 and 6

Sponsors and collaborators

Lead sponsor

Liliana Berenice Ramírez Domínguez

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 26, 2023
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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