Detection of the Uterine Abnormalities Missed in an Ultrasound Scan and/or Hysterosalpingography Using Hysteroscopy, in Females Presenting With Unexplained Infertility

Not Applicable

Completed

• Conditions: Infertility, Female

• Registration Number: NCT04179253
• Lead Sponsor: Beni-Suef University

Brief Summary

Hysteroscopy is still considered the gold standard procedure for uterine cavity exploration. Therefore, many specialists have used hysteroscopy as their first-line of routine exam for infertility patients regardless of guidelines. Thus, scheduling the office micro hysteroscopy as one of the routine steps in the fertility workup program has become mandatory before the final diagnosis of unexplained infertility.

Detailed Description

Although hysteroscopy is generally accepted as the gold standard in diagnosis and treatment of uterine cavity pathology, many gynecologist are reluctant to perform hysteroscopy as an initial test without a high degree of suspicion for pathology due to the need for anesthesia in an operating room setting. The basic infertility work-up has included a HSG to evaluate the uterine cavity and tubal patency. However, HSG does not allow for simultaneous correction of uterine pathology. Moreover HSG may miss 35% of uterine abnormalities. Hysterolaparoscopy (Pan Endoscopic) approach is better than HSG and should be encouraged as first and final procedure in selected infertile women.

Sonohysterography (SHG) has been proposed as a better diagnostic test of the uterine cavity. However, it also suffers from a sensitivity and specificity inferior to that of hysteroscopy in most studies.

Study Timeline

• Study Start: 2018-04-14
• Primary Completion: 2019-04-14
• Study Completion: 2019-04-14
• Status Verified: 2019-11
• Study First Submitted: 2019-11-24
• Study First Submitted QC: 2019-11-26
• Last Update Submitted: 2019-11-26
• Study First Posted: 2019-11-27
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Normal HSG
• Normal Ultrasound
• Normal Hormonal Profile
• Normal Semen

Exclusion Criteria

• Abnormal findings in different investigations of infertility

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Abnormal hysteroscopic findings	one year	Description of different hysteroscopic abnormalities using micro-office hysteroscope

Trial Locations

Locations (1)

Beni-Suef University; 🇪🇬 Cairo, Egypt