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OpenTrials
Completed

NCT Number: NCT04179253

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

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.

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beni-Suef University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Abnormal findings in different investigations of infertility

Treatment and study plan

office micro hysteroscopy

Diagnostic Test

One hundred women with unexplained infertility recruited for office micro hysteroscopic sessions. A rigid fiberoptic 2-mm, 0 and 30 degrees angled hysteroscopy along with an operative channel for grasping forceps or scissors were used for both diagnostic and operative indications. The findings, complications, and patient tolerance were recorded.

Primary outcomes

  1. Abnormal hysteroscopic findings

    Time frame: one year

    Description of different hysteroscopic abnormalities using micro-office hysteroscope

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Hysteroscopic Evaluation of Uterine Cavity in Women With Unexplained Infertility

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 27, 2019
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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