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Screening for Uterine Cavity Abnormalities in Women Scheduled for IVF

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
three dimensional ultrasound
Office hysteroscopy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infertility focused on measuring Assisted reproductive technology

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • History of primary infertility
  • Normal uterine cavity on HSG
  • Women were selected for IVF therapy.

Exclusion Criteria:

  • Women with known diagnosis of uterine abnormality by office hysteroscopy

Sites / Locations

  • Assiut university

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Three dimensional ultrasound

Office hysteroscopy

Arm Description

Three dimensional ultrasound evaluated the uterine cavity for cavitary lesions

Office hystrescopy evaluated the uterine cavity for cavitary lesions

Outcomes

Primary Outcome Measures

Number of patients who have cavitary lesion by three dimensional ultrasound

Secondary Outcome Measures

Full Information

First Posted
November 5, 2015
Last Updated
August 10, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02598921
Brief Title
Screening for Uterine Cavity Abnormalities in Women Scheduled for IVF
Official Title
Determining an Accurate and Cost-effective Strategy for Screening for Uterine Cavity Abnormalities in Women Scheduled for IVF
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluation of the endometrial cavity is an important step in the infertility work-up, particularly if assisted reproductive therapy is planned. The aim is to identify possible endometrial abnormalities that may impair implantation.Undiagnosed endometrial abnormalities are present in 11 to 45% of women scheduled for in vitro fertilization (IVF).Traditionally, two dimensional transvaginal ultrasound (2D TVUS) and hysterosalpingography (HSG) are the basic methods for assessment of the endometrial cavity. However, these imaging modalities have shown high false negative rates among infertile women, a finding that could confine their rule to initial screening rather than definite diagnosis. Office hysteroscopy (OH) is the gold standard for evaluation of the endometrial cavity. Although the endoscopic approach has been proven to increase pregnancy rate in women who experienced prior implantation failure, evidence on treatment of unsuspected hysteroscopically-diagnosed endometrial lesions, to improve IVF outcome, is still lacking. Nevertheless,clinicians tend to use OH routinely prior to IVF because the psychological and financial burden that infertile couples may experience as a consequence of failed IVF cycle is unjustifiable.Yet, costs and invasiveness of OH counteract its global implementation to all women prior to IVF.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Assisted reproductive technology

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Three dimensional ultrasound
Arm Type
Other
Arm Description
Three dimensional ultrasound evaluated the uterine cavity for cavitary lesions
Arm Title
Office hysteroscopy
Arm Type
Other
Arm Description
Office hystrescopy evaluated the uterine cavity for cavitary lesions
Intervention Type
Radiation
Intervention Name(s)
three dimensional ultrasound
Intervention Type
Device
Intervention Name(s)
Office hysteroscopy
Primary Outcome Measure Information:
Title
Number of patients who have cavitary lesion by three dimensional ultrasound
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of primary infertility Normal uterine cavity on HSG Women were selected for IVF therapy. Exclusion Criteria: Women with known diagnosis of uterine abnormality by office hysteroscopy
Facility Information:
Facility Name
Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

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Screening for Uterine Cavity Abnormalities in Women Scheduled for IVF

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