Examining the junctional zone's impact on pregnancy outcomes in assisted reproductive technology
Uterine Junctional Zone Evaluation on 3D Ultrasound and Its Relation to Major Adverse Obstetrical Outcomes in Assisted Reproductive Technology
This study is testing if looking at a specific part of the uterus with 3D ultrasound can help predict pregnancy problems in women aged 18 to 42 who are using assisted reproductive technology like IVF.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Centro Hospitalar Lisboa Norte Academic / other |
| Locations | 3 sites (Funchal, Madeira and 2 other locations) |
| Trial ID | NCT05763498 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between the characteristics of the junctional zone (JZ) as visualized by 3D ultrasound and adverse obstetrical outcomes in women undergoing assisted reproductive technology (ART) treatments. The JZ is a crucial layer of the myometrium that plays a significant role in placentation and may be linked to complications such as pre-term labor and fetal growth restriction. By assessing the JZ prior to conception, the study aims to identify women at risk for these complications, thereby enhancing understanding of the mechanisms behind defective deep placentation. The study will involve women aged 18 to 42 years who are undergoing IVF, ICSI, or endometrial preparation for frozen embryo transfer.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 42 years undergoing IVF, ICSI, or endometrial preparation for frozen embryo transfer.
Not a fit: Patients with myomas, adenomyosis, or endometriosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify women at risk for major obstetrical complications, leading to improved pregnancy outcomes.
How similar studies have performed: While the specific approach of assessing the JZ in relation to ART outcomes is novel, there is growing interest in the role of myometrial characteristics in obstetrical complications.
Eligibility criteria
Show full inclusion / exclusion 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 * endometriosis
Where this trial is running
Funchal, Madeira and 2 other locations
- Hospital Central do Funchal — Funchal, Madeira, Portugal (Not_yet_recruiting)
- Departamento de Obstetricia, Ginecologia e Medicina da Reprodução — Lisbon, Portugal (Recruiting)
- Centro Hospitalar Universitário Lisboa Norte — Lisbon, Portugal (Recruiting)
Study contacts
- Principal investigator: Isabel B Pereira, M.D — Centro Hospitalar Lisboa Norte
- Study coordinator: Isabel B Pereira, M.D.
- Email: isabelsofiapereira@yahoo.com
- Phone: +351967053610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.