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NCT04878224

Junctional Zone and Its Relation to Outcomes in Assisted Reproductive Technology

Recruiting now Last updated 20 August 2024
What this trial tests

trial in Infertility, Female in 200 participants. Currently enrolling.

Timeline
1 June 2021
Primary endpoint
31 January 2025
31 January 2025

Quick facts

Lead sponsorCentro Hospitalar Lisboa Norte
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment200
Start date1 June 2021
Primary completion31 January 2025
Estimated completion31 January 2025
Sites1 location across Portugal

Conditions studied

Sponsor

Centro Hospitalar Lisboa Norte

Who can join

Adults 18 to 42, female only, with Infertility, Female. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The junctional zone (JZ) is an internal layer of the myometrium, with unique characteristics that allow its visualization as a hypoechogenic structure in three-dimensional (3D) ultrasound. Although traditionally evaluated by magnetic resonance imaging, 3D reconstruction offers an opportunity for reliable and easily accessible assessment. The only study that evaluated the thickness of the JZ in 3D ultrasound in the context of assisted reproductive technology (ART) found that the smaller the thickness of the JZ, the greater the rate of embryonic implantation. This project aims to evaluate the relationship between the characteristics of the ZJ in 3D ultrasound, and the clinical outcomes of ART treatments, namely in vitro fertilization cycles, intracytoplasmic sperm injection and frozen embryo transfer (FET). Additionally, the intra and inter-observer variability of the characteristics of the JZ will be determined. In a prospective and observational study with the inclusion of 200 cases, a 3D ultrasound will be performed on the day on which the final oocyte maturation is triggered or, on FET, on the day prior to the administration of progesterone. The images will be evaluated independently by two observers. The principal investigator will evaluate the images in two stages. After the quality of visualization of the JZ is classified, its thickness will be measured and described as regular, irregular or interrupted. The volume of the ZJ will be obtained by subtracting the endometrial volume from the volume of the junctional zone and the endometrium. These characteristics will be related to the clinical outcomes of each cycle: clinical pregnancy rate and abortion rate.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

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