Screening for Uterine Cavity Abnormalities in Women Scheduled for IVF

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Radiation: three dimensional ultrasound; Device: Office hysteroscopy

• Registration Number: NCT02598921
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2015-08
• Study Completion: 2015-10
• Study First Submitted: 2015-11-05
• Study First Submitted QC: 2015-11-05
• Study First Posted: 2015-11-06
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-10
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Three dimensional ultrasound	three dimensional ultrasound	Three dimensional ultrasound evaluated the uterine cavity for cavitary lesions
Office hysteroscopy	Office hysteroscopy	Office hystrescopy evaluated the uterine cavity for cavitary lesions

Primary Outcome Measures

Name	Time	Method
Number of patients who have cavitary lesion by three dimensional ultrasound	1 year

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt