Screening for Uterine Cavity Abnormalities in Women Scheduled for IVF
Determining an Accurate and Cost-effective Strategy for Screening for Uterine Cavity Abnormalities in Women Scheduled for IVF
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 5, 2015
CompletedFirst Posted
Study publicly available on registry
November 6, 2015
CompletedAugust 12, 2020
August 1, 2020
1.1 years
November 5, 2015
August 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients who have cavitary lesion by three dimensional ultrasound
1 year
Study Arms (2)
Three dimensional ultrasound
OTHERThree dimensional ultrasound evaluated the uterine cavity for cavitary lesions
Office hysteroscopy
OTHEROffice hystrescopy evaluated the uterine cavity for cavitary lesions
Interventions
Eligibility Criteria
You may qualify if:
- History of primary infertility
- Normal uterine cavity on HSG
- Women were selected for IVF therapy.
You may not qualify if:
- Women with known diagnosis of uterine abnormality by office hysteroscopy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut university
Asyut, 71111, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
November 5, 2015
First Posted
November 6, 2015
Study Start
July 1, 2014
Primary Completion
August 1, 2015
Study Completion
October 1, 2015
Last Updated
August 12, 2020
Record last verified: 2020-08