Screening for Uterine Cavity Abnormalities in Women Scheduled for IVF

NCT ID: NCT02598921

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-10-31

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.

Conditions

Infertility

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Three dimensional ultrasound

Three dimensional ultrasound evaluated the uterine cavity for cavitary lesions

Group Type: OTHER

three dimensional ultrasound

Intervention Type: RADIATION

Office hysteroscopy

Office hystrescopy evaluated the uterine cavity for cavitary lesions

Group Type: OTHER

Office hysteroscopy

Intervention Type: DEVICE

Interventions

three dimensional ultrasound

Intervention Type: RADIATION

Office hysteroscopy

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Khairy Ali

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut university

Asyut, , Egypt

Countries

Egypt

Other Identifiers

IVF

Identifier Type: -

Identifier Source: org_study_id