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NCT Number: NCT04878224

Junctional Zone and Its Relation to Outcomes in Assisted Reproductive Technology

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.

Recruiting

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Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

Centro Hospitalar Universitário Lisboa Norte

Lisbon, Portugal

Location status: Recruiting

Location contact

Isabel Barros Pereira, M.D.

CONTACT

00351967053610

About this study

After explaining the study and obtaining written consent, a 3D ultrasound will be performed for uterine evaluation, on the day of the final oocyte maturation trigger in cases of IVF / ICSI. In cases of FET, the ultrasound evaluation will be carried out on the day before the start of the luteal phase support.

All ultrasounds will be performed in a standardized manner by the same operator. With an empty bladder, in a lithotomy position, a 2D transvaginal ultrasound will be performed using a GE Voluson 730 Expert® ultrasound, with an endovaginal probe with a 4-8MHz frequency. Identification of endometriosis lesions or acquired uterine abnormalities such as leiomyomas or adenomyosis will be exclusion criteria. After evaluating the number and maximum dimension of the ovarian follicles and the endometrial thickness, the three-dimensional volume box will be placed to encompass the entire uterus in longitudinal section, with minimal inclusion of para-uterine structures. A maximum acquisition angle of 90º and maximum quality will be used. To minimize artifacts, during the acquisition both the probe and the woman must remain immobile, being asked to hold their breath. Then, a three-dimensional volume will be generated by automatic 360º rotation of the transducer. For each case, two volumes will always be obtained.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women followed in the infertility clinic
  • aged between 18 and 42 years in cycles of IVF, ICSI or endometrial preparation for frozen embryo transfer

Exclusion criteria

  • Myomas
  • adenomyosis

Treatment and study plan

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: 7 weeks

    Clinical pregnancy rate

  2. Abortion rate

    Time frame: 7 weeks

    Abortion rate

Secondary outcomes

  1. intra-observer variability

    Time frame: 2 years

    intra-observer variability

  2. inter-observer variability

    Time frame: 2 years

    inter-observer variability

Study contacts

Contact information is provided by the study sponsor or research team.

Isabel Barros Pereira, M.D.

CONTACT

[email protected]

00351967053610

Isabel Barros Pereira, M.D.

CONTACT

00351967053610

Sponsors and collaborators

Lead sponsor

Centro Hospitalar Lisboa Norte

Other

Registry information

Official study title

Junctional Zone Evaluation by 3D Ultrasound and Its Relation to Clinical Outcomes in Assisted Reproductive Technology

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 7, 2021
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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