Junctional Zone and Its Relation to Outcomes in Assisted Reproductive Technology

NCT04878224 | Recruiting DMC

• 1 other identifier: ZJ
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female

Keywords

infertility; ultrasound

Outcome Measures

Primary Outcomes (2)

• Clinical pregnancy rate

  Clinical pregnancy rate

  7 weeks

• Abortion rate

  Abortion rate

  7 weeks

Secondary Outcomes (2)

• intra-observer variability

  2 years

• inter-observer variability

  2 years

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women included are followed in the fertility clinic aged between 18 and 40 years in cycles of IVF, ICSI or endometrial preparation for frozen embryo transfer

You may qualify if:

• Women followed in the infertility clinic
• aged between 18 and 42 years in cycles of IVF, ICSI or endometrial preparation for frozen embryo transfer

You may not qualify if:

• Myomas
• adenomyosis

Sponsors & Collaborators

• Centro Hospitalar Lisboa Norte: lead

Study Sites (1)

Centro Hospitalar Universitário Lisboa Norte

Lisbon, Portugal

RECRUITING

MeSH Terms

Conditions

Infertility, Female; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Isabel Barros Pereira, M.D.

  Centro Hospitalar Universitário Lisboa Norte

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabel Barros Pereira, M.D.

CONTACT

00351967053610; isabelsofiapereira@yahoo.com

Isabel Barros Pereira, M.D.

CONTACT

00351967053610

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 7, 2021
• Study Start: June 1, 2021
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

PT (1)