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Infertility, FemaleNCT05763498

Uterine Junctional Zone and Its Relation to Adverse Obstetrical Outcomes in Assisted Reproductive Technology

An observational study of Infertility, Female, run by Centro Hospitalar Lisboa Norte at 3 sites in Portugal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Infertility, Female
How many people
200 participants
Where
3 sitesPortugal
Study dates
24 Feb 2023to 31 Jul 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Adult

Study population: Women included are followed in the fertility clinic aged between 18 and 40 years in cycles of IVF, ICSI or endometrial preparation for frozen embryo transfer

Who may be able to join

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

Who cannot join

  • Myomas
  • adenomyosis
  • endometriosis

Trial locations and contacts

3 sites in 1 country.

Isabel B Pereira, M.D. contact

+351967053610

isabelsofiapereira@yahoo.com

Isabel B Pereira, M.D contact

+351967053610

isabelsofiapereira@yahoo.com

Portugal3 sites, 3 recruiting
  • Hospital Central do Funchal

    Funchal, Madeira, 9000

    Isabel B Pereira, +351967053610, isabelsofiapereira@yahoo.com

    Not yet recruiting
  • Departamento de Obstetricia, Ginecologia e Medicina da Reprodução

    Lisbon, 1600

    Isabel Barros Pereira, M.D.

    Recruiting
  • Centro Hospitalar Universitário Lisboa Norte

    Lisbon

    Isabel Barros Pereira, M.D., 00351967053610

    Recruiting

Other trials in Portugal

About this study

Official title: Uterine Junctional Zone Evaluation on 3D Ultrasound and Its Relation to Major Adverse Obstetrical 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.

While there is a growing realization that the origins of major obstetrical complications associated with defective deep placentation, such as pre-term labour, fetal growth restriction and pre-eclampsia, may lie in the very early pregnancy events, the underlying mechanisms are not understood.

Read the detailed description

During pregnancy, unique vascular changes occur, associated with decidualization of the maternal tissues in response to trophoblast invasion, first in the endometrium and subsequently in the myometrial JZ. The JZ broadly represents the inner third of the myometrium that, together with its overlying endometrium, is involved in placentation.

Defective deep placentation, defined by the absent or incomplete remodelling of the JZ segment of the spiral arteries, may be associated with a spectrum of obstetrical complications, ranging from late miscarriage and pre-term labour to fetal growth restriction and pre-eclampsia.

Thus, the primary site of vascular pathology in pregnancies lies not in the placenta or decidua but in the JZ. To understand how impaired remodelling of the myometrial JZ prior to conception may predispose to subsequent defective deep placentation, it is important to first describe the structural and functional changes in the JZ at the time of embryo implantation, and subsequently analyse the distinguishing features of defective deep placentation associated with different pregnancy disorders.

Thus, non-invasive assessment of the JZ prior to conception may turn out to be useful in identifying those women at risk of major obstetrical complications.

This project aims to evaluate the relationship between the characteristics of the ZJ in 3D ultrasound, and major adverse obstetrical outcomes in assisted reproductive technology (ART) treatments, namely in vitro fertilization cycles, intracytoplasmic sperm injection and frozen embryo transfer (FET).

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.

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 major obstetrical adverse outcomes: pre-eclampsia, pre-term labour and fetal growth restriction. The relation with a high-risk first trimester screening for pre-eclampsia will also be accessed.

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.

Keywords
infertility, 3D ultrasound, junctional zone
Medical subject headings
Infertility, Female, Infertility

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pre-eclampsia

    Pre-eclampsia rate

    Measured: 40 weeks

  2. pre-term labour

    pre-term labour rate

    Measured: 37 weeks

  3. Fetal growth restriction

    Fetal growth restriction rate

    Measured: 40 weeks

Secondary outcomes (1)
  1. High-risk first trimester screening for pre-eclampsia

    High-risk first trimester screening for pre-eclampsia rate

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2023
  2. Study start24 Feb 2023
  3. Primary completion28 Feb 2025 (estimated)
  4. Study completion31 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05763498
Sponsor's protocol ID
JZ OO
Status last verified
Aug 2024
First submitted
27 Feb 2023
Last updated
20 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Infertility, Female, run by Centro Hospitalar Lisboa Norte at 3 sites in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Isabel B Pereira, M.D. (+351967053610, isabelsofiapereira@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pre-eclampsia (time frame: 40 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.

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