CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 293 enrolled
Drug / intervention
EmbryORP® +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05919186
NCT05919186N/ACompleted

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

Liliana Berenice Ramírez Domínguez·interventional·Posted Jun 26, 2023·Updated Jun 26, 2023

In Brief

A clinical study evaluating EmbryORP®, O2 tension 20%, and 1 other intervention for Infertility, Female and Infertility, Male. Completed, enrolled 293 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJun 26, 2023
Enrollment StartOct 12, 2021
Primary CompletionApr 12, 2022
Study CompletionMay 10, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 3.0 years ago

Interventions

EmbryORP®drug

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

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%