Can a Differentiated Oxygen Setup Improve Embryo Quality and Increase the Number of Usable Embryos After in Vitro Fertilization (IVF)?

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 41
Healthy Volunteers: t
View:

• Patients undergoing assisted reproductive technology (ART), with planned IVF or intracytoplasmic sperm injection (ICSI) cycles.

• Women age 18 - 41 years and BMI 18 - 35 kg/m2 (both inclusive) with ≥ 8 oocytes.

• Patients will be included no later than at oocyte pick-up.

Locations
Other Locations
Denmark
Odense University Hospital
RECRUITING
Odense
Contact Information
Primary
Tilde Eskildsen
tilde.veng.eskildsen@rsyd.dk
+4565412324
Backup
Kirsten Simonsen
ks@maigaard.dk
+4586101388
Time Frame
Start Date: 2022-09-15
Estimated Completion Date: 2025-12
Participants
Target number of participants: 350
Treatments
No_intervention: Control group
The oocytes from a patient, retrieving more than 8 oocytes will be divided into 2 sibling groups. The control group and the study group.~The first part of the collected oocytes, will be included as controls. If an unequal numbers of oocytes are collected, the extra oocyte will be included into the control group.~Control oocytes are, after fertilization, placed in conventional 5% O2 incubators and cultured herein for 5 days.
Experimental: Study group
The second part of the collected oocytes, from a patient retrieving more than 8 oocytes, will be included as study group.~Study oocytes, are after fertilization, placed and cultured in conventional 5% O2 incubators for the first 3 days. At day 3, the embryos are moved to an incubator with 2% O2 tension and cultured until day 5.
Related Therapeutic Areas
Sponsors
Leads: Odense University Hospital
Collaborators: University of Southern Denmark, Odense Patient Data Explorative Network

This content was sourced from clinicaltrials.gov