NCT04878224 Junctional Zone and Its Relation to Outcomes in Assisted Reproductive Technology
| NCT ID | NCT04878224 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centro Hospitalar Lisboa Norte |
| Condition | Infertility, Female |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2025-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2021-06-01 with a primary completion date of 2025-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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.
Eligibility Criteria
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
Contact & Investigator
Isabel Barros Pereira, M.D.
PRINCIPAL INVESTIGATOR
Centro Hospitalar Universitário Lisboa Norte
Frequently Asked Questions
Who can join the NCT04878224 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 42 Years, studying Infertility, Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04878224 currently recruiting?
Yes, NCT04878224 is actively recruiting participants. Contact the research team at isabelsofiapereira@yahoo.com for enrollment information.
Where is the NCT04878224 trial being conducted?
This trial is being conducted at Lisbon, Portugal.
Who is sponsoring the NCT04878224 clinical trial?
NCT04878224 is sponsored by Centro Hospitalar Lisboa Norte. The principal investigator is Isabel Barros Pereira, M.D. at Centro Hospitalar Universitário Lisboa Norte. The trial plans to enroll 200 participants.