NCT05763498

Brief 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. 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

February 27, 2023

Last Update Submit

August 19, 2024

Conditions

Keywords

infertility3D ultrasoundjunctional zone

Outcome Measures

Primary Outcomes (3)

  • Pre-eclampsia

    Pre-eclampsia rate

    40 weeks

  • pre-term labour

    pre-term labour rate

    37 weeks

  • Fetal growth restriction

    Fetal growth restriction rate

    40 weeks

Secondary Outcomes (1)

  • High-risk first trimester screening for pre-eclampsia

    12 weeks

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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

You may qualify if:

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

You may not qualify if:

  • Myomas
  • adenomyosis
  • endometriosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Central do Funchal

Funchal, Madeira, 9000, Portugal

NOT YET RECRUITING

Departamento de Obstetricia, Ginecologia e Medicina da Reprodução

Lisbon, 1600, Portugal

RECRUITING

Centro Hospitalar Universitário Lisboa Norte

Lisbon, Portugal

RECRUITING

MeSH Terms

Conditions

Infertility, FemaleInfertility

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Isabel B Pereira, M.D

    Centro Hospitalar Lisboa Norte

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabel B Pereira, M.D.

CONTACT

Isabel B Pereira, M.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 10, 2023

Study Start

February 24, 2023

Primary Completion

February 28, 2025

Study Completion

July 31, 2025

Last Updated

August 20, 2024

Record last verified: 2024-08

Locations