Screening for Uterine Cavity Abnormalities in Women Scheduled for IVF

Study Overview
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Brief Summary
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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.

Official Title
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Determining an Accurate and Cost-effective Strategy for Screening for Uterine Cavity Abnormalities in Women Scheduled for IVF

Conditions
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Infertility

Intervention / Treatment
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* Radiation: three dimensional ultrasound
* Device: Office hysteroscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Three dimensional ultrasound<br>Three dimensional ultrasound evaluated the uterine cavity for cavitary lesions | Radiation: three dimensional ultrasound<br> <br> |
| Other: Office hysteroscopy<br>Office hystrescopy evaluated the uterine cavity for cavitary lesions | Device: Office hysteroscopy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who have cavitary lesion by three dimensional ultrasound |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Assisted reproductive technology