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Junctional Zone and Its Relation to Outcomes in Assisted Reproductive Technology

Junctional Zone Evaluation by 3D Ultrasound and Its Relation to Clinical Outcomes in Assisted Reproductive Technology

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04878224
Enrollment
200
Registered
2021-05-07
Start date
2021-06-01
Completion date
2025-01-31
Last updated
2024-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Female

Keywords

infertility, ultrasound

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.

Detailed 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.

Interventions

None listed

Sponsors

Centro Hospitalar Lisboa Norte
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical pregnancy rate7 weeksClinical pregnancy rate
Abortion rate7 weeksAbortion rate

Secondary

MeasureTime frameDescription
inter-observer variability2 yearsinter-observer variability
intra-observer variability2 yearsintra-observer variability

Countries

Portugal

Contacts

Primary ContactIsabel Barros Pereira, M.D.
isabelsofiapereira@yahoo.com00351967053610
Backup ContactIsabel Barros Pereira, M.D.
00351967053610

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026