Actively Recruiting

Age: 18Years - 42Years
FEMALE
Healthy Volunteers
NCT04878224

Junctional Zone and Its Relation to Outcomes in Assisted Reproductive Technology

Led by Centro Hospitalar Lisboa Norte · Updated on 2024-08-20

200

Participants Needed

1

Research Sites

191 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Junctional Zone and Its Relation to Outcomes in Assisted Reproductive Technology

Who Can Participate

Age: 18Years - 42Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women followed in the infertility clinic
  • Aged between 18 and 42 years
  • Undergoing IVF, ICSI, or endometrial preparation for frozen embryo transfer cycles
Not Eligible

You will not qualify if you...

  • Presence of myomas
  • Diagnosis of adenomyosis

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Centro Hospitalar Universitário Lisboa Norte

Lisbon, Portugal

Actively Recruiting

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Research Team

I

Isabel Barros Pereira, M.D.

CONTACT

I

Isabel Barros Pereira, M.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Junctional Zone and Its Relation to Outcomes in Assisted Reproductive Technology | DecenTrialz