Effects of Antioxidant Supplementation of Culture Media on IVF Embryos

Liliana Berenice Ramírez Domínguez

Status: Completed

Conditions: Infertility, Male; Infertility, Female

Treatments: Device: O2 tension 5%; Drug: EmbryORP®; Device: O2 tension 20%

Study type: Interventional

Funder types: Industry

Identifiers

NCT05919186

CI-20-102

Details and patient eligibility

About

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.

Full 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.

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Enrollment: 293 patients

Sex: Female

Ages: 18 to 37 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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293 participants in 4 patient groups

EmrbyORP continued at high O2

Experimental group

Description:

Antioxidants supplementation Every 12 hours (3.5 μL)

Treatment:

Drug: EmbryORP®

Device: O2 tension 20%

EmrbyORP at baseline with high O2

Experimental group

Description:

Antioxidants supplementation At baseline only (6.5 μL)

Treatment:

Drug: EmbryORP®

Device: O2 tension 20%

EmrbyORP continued at low 02

Experimental group

Description:

Antioxidants supplementation Every 12 hours (3.5 μL)

Treatment:

Device: O2 tension 5%

Drug: EmbryORP®

EmrbyORP at baseline with low o2

Experimental group

Description:

Antioxidants supplementation At baseline only (6.5 μL)

Treatment:

Device: O2 tension 5%

Drug: EmbryORP®