Ultrasonographic Measurements of Uterine Junctional Zone... | NCT03147144

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

NCT03147144

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

May 10, 2017Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Infertility, Female

Interventions

Ultrasonographic imaging

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2017Estimated

Primary Completion Date

May 2018Estimated

Completion Date

May 2018Estimated

First Submitted Date

May 8, 2017

First Submission Date that Met QC Criteria

May 8, 2017

First Posted Date

May 10, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2017

Last Update Posted Date

May 10, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Name	Type	Description	Arm Group Labels	Other Names
Ultrasonographic imaging	Other	Ultrasound pelvic scan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Thickened uterine junctional zone	Observed and measured by ultrasound	2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Women attending the IVF clinic at Hillel Yaffe Medical Center

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Livna Shafat Heller, MD	Contact	972-50-3321230		livnashafat@gmail.com

Overall Officials

Name	Affiliation	Role
Livna Shafat Heller, MD	Hillel Yaffe Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera		38100	Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007247	Infertility, Female

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019220	High-Energy Shock Waves

Ancestor Terms

ID	Term
D000069453	Ultrasonic Waves
D013016	Sound
D011840	Radiation, Nonionizing
D011827	Radiation

Browse Leaves

Not provided

Browse Branches

Not provided