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Ultrasonographic Measurements of Uterine Junctional Zone and Association With In Vitro Fertilization Treatment Outcome

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ClinicalTrials.gov Identifier: NCT03147144
Recruitment Status : Not yet recruiting
First Posted : May 10, 2017
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Brief Summary:
The aim of this study is to prospectively examine the relationship of the uterine junctional zone thickness, evaluated by ultrasonography and In Vitro Fertilization (IVF) treatment outcome. The study hypothesis is that the uterine junctional zones of women who did not achieve pregnancy will be thicker than those of the women who do achieve pregnancy

Condition or disease Intervention/treatment
Infertility, Female Other: Ultrasonographic imaging

Detailed Description:

Ultrasounds of women who achieve pregnancy after IVF treatment will be compared to ultrasounds of women who do not achieve pregnancy. Their uterine junctional zone thickness will be compared.

The study hypothesis is that the uterine junctional zones of women who did not achieve pregnancy will be thicker than those of the women who do achieve pregnancy.


Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasonographic Measurements of Uterine Junctional Zone and Association With In Vitro Fertilization Treatment Outcome
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Ultrasonographic imaging
    Ultrasound pelvic scan


Primary Outcome Measures :
  1. Thickened uterine junctional zone [ Time Frame: 2 months ]
    Observed and measured by ultrasound



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Sampling Method:   Probability Sample
Study Population
Women attending the IVF clinic at Hillel Yaffe Medical Center
Criteria

Inclusion Criteria:

  • Undergoing IVF treatment due to male factor, polycystic ovary syndrome and unexplained infertility

Exclusion Criteria:

  • Low ovarian reserve
  • Having undergone more than one D&C

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03147144


Contacts
Contact: Livna Shafat Heller, MD 972-50-3321230 livnashafat@gmail.com

Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
H̱adera, Israel, 38100
Contact: Livna Shafat Heller, MD    972-50-3321230    livnashafat@gmail.com   
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
Principal Investigator: Livna Shafat Heller, MD Hillel Yaffe Medical Center

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT03147144     History of Changes
Other Study ID Numbers: HYMC-0031-17
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female