Effects of Antioxidant Supplementation of Culture Media on IVF Embryos

June 22, 2023 updated by: Liliana Berenice Ramírez Domínguez

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

.

Study Type

Interventional

Enrollment (Actual)

293

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 11520
        • CITMER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EmrbyORP continued at high O2
Antioxidants supplementation Every 12 hours (3.5 μL)
Drug: EmbryORP®
EmbryORP® is a novel antioxidant (Cystein 32.9 mM, Glutation 32.6 mM, Ascorbic Acid 22.7 mM)
Other Names:
  • EmbryORP
Device: O2 tension 20%
After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2, and 95%
Experimental: EmrbyORP at baseline with high O2
Antioxidants supplementation At baseline only (6.5 μL)
Drug: EmbryORP®
EmbryORP® is a novel antioxidant (Cystein 32.9 mM, Glutation 32.6 mM, Ascorbic Acid 22.7 mM)
Other Names:
  • EmbryORP
Device: O2 tension 20%
After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2, and 95%
Experimental: EmrbyORP continued at low 02
Antioxidants supplementation Every 12 hours (3.5 μL)
Drug: EmbryORP®
EmbryORP® is a novel antioxidant (Cystein 32.9 mM, Glutation 32.6 mM, Ascorbic Acid 22.7 mM)
Other Names:
  • EmbryORP
Device: O2 tension 5%
After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2 and 95%
Experimental: EmrbyORP at baseline with low o2
Antioxidants supplementation At baseline only (6.5 μL)
Drug: EmbryORP®
EmbryORP® is a novel antioxidant (Cystein 32.9 mM, Glutation 32.6 mM, Ascorbic Acid 22.7 mM)
Other Names:
  • EmbryORP
Device: O2 tension 5%
After fertilization check, zygotes were placed in the incubator at 37°C, 8% CO2 and 95%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 days
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
5 days
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
6 days
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
6 days
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
5 - 6 days
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
5 - 6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liliana Berenice Ramírez Domínguez

Investigators

  • Study Director: Ashok Agarwal, PhD, Global Andrology Forum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2021

Primary Completion (Actual)

April 12, 2022

Study Completion (Actual)

May 10, 2022

Study Registration Dates

First Submitted

May 12, 2023

First Submitted That Met QC Criteria

June 22, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 22, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI-20-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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