Screening for Uterine Cavity Abnormalities in Women Scheduled for IVF

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02598921
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Radiation: three dimensional ultrasound; Device: Office hysteroscopy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Determining an Accurate and Cost-effective Strategy for Screening for Uterine Cavity Abnormalities in Women Scheduled for IVF
• Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Three dimensional ultrasound Three dimensional ultrasound evaluated the uterine cavity for cavitary lesions	Radiation: three dimensional ultrasound
Other: Office hysteroscopy Office hystrescopy evaluated the uterine cavity for cavitary lesions	Device: Office hysteroscopy

Outcome Measures

Primary Outcome Measures

1. Number of patients who have cavitary lesion by three dimensional ultrasound [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut university	Assiut		Egypt	71111

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohammed Khairy Ali, Dr, Assiut University
• ClinicalTrials.gov Identifier: NCT02598921
• Other Study ID Numbers: IVF
• First Posted: Nov 6, 2015
• Last Update Posted: Aug 12, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mohammed Khairy Ali, Dr, Assiut University: Assisted reproductive technology
• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of Aug 12, 2020