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Effects of Antioxidant Supplementation of Culture Media on IVF Embryos

NCT05919186 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 293

Last updated 2023-06-26

No results posted yet for this study

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.

Conditions

  • Infertility, Female
  • Infertility, Male

Interventions

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%

Sponsors & Collaborators

  • Liliana Berenice Ramírez Domínguez

    lead INDUSTRY

Principal Investigators

  • Ashok Agarwal, PhD · Global Andrology Forum

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
37 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-12
Primary Completion
2022-04-12
Completion
2022-05-10

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05919186 on ClinicalTrials.gov