Quality of Human Embryos in IVF, Culturing in Differentiated Oxygen

Summary

The goal of this clinical trial is to evaluate the importance of differential O2 tension to the developing embryos. As a secondary aim, we investigate the levels of reactive oxygen species (ROS) in spent media from the developing blastocysts.

This is a prospective, interventional multicenter study using sibling embryos.

Woman (age 18-41 and normal weight) undergoing assisted reproductive technology (ART) can be included in the study.

Patients included in the project will follow standard IVF protocol and treatment.

By retrieving ≥ 8 oocytes after pickup and upon prior acceptance by the patient, she/the couple can be included in the study.

According to standard treatment, both groups of oocytes will be placed in an incubator with 5% O2.After 3 days of cultivation, the dishes with the study-embryos will be transferred to an incubator with 2% O2. The control embryos will remain in the conventional 5% O2 incubator.

On the fifth day, the embryos will be evaluated, and the blastocyst with expected greatest implantation potential will be transferred to the patients uterus. Surplus embryos with expected implantation potential will be cryopreserved. After transfer or cryopreservation, the media from the wells with used blastocysts will be collected and stored for ROS analysis.

Value for public Health:

If our hypothesis is confirmed, we will be able to optimize the developmental conditions and decreased ROS levels for the embryo in vitro. From a clinical perspective, this could affect the implantation rate of the blastocyst and thus the success of pregnancies for infertile couples while reducing the number of treatments to obtain a viable pregnancy.

Conditions

• Infertility
• IVF
• Embryo

Interventions

OTHER

Differential oxygen tension

By culturing the embryos in a differential O2 set-up, changing the O2 tension from reduced (5% O2) to ultralow (2% O2) from day 3 to day 5 of embryo development in vitro, we mimic the physiological differential changes in O2 as the embryo migrate from the oviduct to the uterus and develops in vivo.

Sponsors & Collaborators

• Odense Patient Data Explorative Network

  collaborator OTHER

• University of Southern Denmark

  collaborator OTHER

• Odense University Hospital

  lead OTHER

Principal Investigators

• Tilde Eskildsen · Odense University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

41 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-09-15

Primary Completion

2024-12-31

Completion

2025-12-31

Countries

• Denmark

Study Locations