Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04878224 |
| Other study ID # |
ZJ |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
January 31, 2024 |
Study information
| Verified date |
February 2023 |
| Source |
Centro Hospitalar Lisboa Norte |
| Contact |
Isabel Barros Pereira, M.D. |
| Phone |
00351967053610 |
| Email |
isabelsofiapereira[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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.
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.
Description:
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.
