Quality of Human Embryos in IVF, Culturing in Differentiated Oxygen

NCT05737381 | Unknown DMC

• 1 other identifier: S-20210143
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Oxygen; Blastocyst; Time lapse; ROS; Embryology

Outcome Measures

Primary Outcomes (1)

• Improved morphokinetics parameters

  Decreased time difference from 5-cell (t5) to full blastocyst stage (tB) in the embryos cultured in differential O2 tensions. This will be analysed using timelapse systems and specific annotation strategies.

  Analysis of morphokinetic, will be finalised approximately 12 months after last intervention.

Secondary Outcomes (3)

• Decreased ROS-activity

  Analysis of ROS will be finalised approximately 12 months after interventions have been completed.

• Number of transferable/frozen blastocyst

  Number count of transferable/vitrified blastocysts will be finalised approximately 6 months after interventions have been complete

• Clinical pregnancy (CP)

  Data of CP from fresh transfers can be finalised 12 months after last intervention. Data of CP from frozen blastocyst can be finalized either within the project or if not used within the following year, in a followup project.

Study Arms (2)

Control group

NO INTERVENTION

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.

Study group

EXPERIMENTAL

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.

Other: Differential oxygen tension

Interventions

Differential oxygen tension OTHER

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.

Study group

Eligibility Criteria

• Age: 18 Years - 41 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients with sperm from testes biopsy, congenital uterine abnormalities, presence of fibromas or polyps, or suspected hydro salpinges. Oocytes from donors.

Sponsors & Collaborators

• Odense University Hospital: lead
• Odense Patient Data Explorative Network: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Tilde Eskildsen

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tilde Eskildsen

CONTACT

+4565412324; tilde.veng.eskildsen@rsyd.dk

Kirsten Simonsen

CONTACT

+4586101388; ks@maigaard.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Intervention for embryos will be masked when performing the morphokinetic and ROS analysis
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sibling study

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 21, 2023
• Study Start: September 15, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: February 27, 2023

Record last verified: 2023-02

Locations

DK (1)