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NCT04878224
Junctional Zone and Its Relation to Outcomes in Assisted Reproductive Technology
trial in Infertility, Female in 200 participants. Currently enrolling.
31 January 2025
Quick facts
| Lead sponsor | Centro Hospitalar Lisboa Norte |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 200 |
| Start date | 1 June 2021 |
| Primary completion | 31 January 2025 |
| Estimated completion | 31 January 2025 |
| Sites | 1 location across Portugal |
Conditions studied
- Infertility, Female — all drugs for Infertility, Female →
Sponsor
Centro Hospitalar Lisboa Norte
Who can join
Adults 18 to 42, female only, with Infertility, Female. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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- PubMed search for NCT04878224
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Other Centro Hospitalar Lisboa Norte trials
Trials by the same sponsor.
- NCT05763498 — Uterine Junctional Zone and Its Relation to Adverse Obstetrical Outcomes in Assisted Reproductive Technology · recruiting
- NCT04271722 — Clinical Evaluation of Cervical Ripening in the Outpatient Setting · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04878224 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centro Hospitalar Lisboa Norte
- Last refreshed: 20 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04878224.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing