Screening for Uterine Cavity Abnormalities in Women Scheduled for IVF

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02598921
• Other study ID #: IVF
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: October 2015

Study information

• Verified date: August 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Radiation:
• three dimensional ultrasound

Device:
• Office hysteroscopy

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who have cavitary lesion by three dimensional ultrasound		1 year