Detection of the Uterine Abnormalities Missed in an Ultrasound Scan and/or Hysterosalpingography Using Hysteroscopy, in Females Presenting With Unexplained Infertility
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|ClinicalTrials.gov Identifier: NCT04179253|
Recruitment Status : Completed
First Posted : November 27, 2019
Last Update Posted : November 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Infertility, Female||Diagnostic Test: office micro hysteroscopy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||One hundred women with unexplained infertility recruited for office micro hysteroscopic session|
|Masking:||None (Open Label)|
|Official Title:||Hysteroscopic Evaluation of Uterine Cavity in Women With Unexplained Infertility|
|Actual Study Start Date :||April 14, 2018|
|Actual Primary Completion Date :||April 14, 2019|
|Actual Study Completion Date :||April 14, 2019|
The patient was placed in the dorsal lithotomy position. Normal saline was used for uterine distension connected to the inflow channel on the sheath with intravenous tubing. The tip of the hysteroscope was positioned in the vaginal introitus, the labia being slightly separated with fingers. The vagina was distended with saline.
The uterine cavity was systematically explored by rotating the fore-oblique scope in order to identify any anomaly in the uterine walls and/or the right and left tubal ostia. At this stage it was crucially important to avoid lateral movements as much as possible to reduce patient discomfort to a minimum. After that, the scope was removed Finally the evaluation and the data that had been found were written in details by the surgeon. Operative intervention was done if needed. Any complication in the form of pain, bleeding, vasovagal attack and perforation, were registered in the patient sheet.
Diagnostic Test: office micro hysteroscopy
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.
- Abnormal hysteroscopic findings [ Time Frame: one year ]Description of different hysteroscopic abnormalities using micro-office hysteroscope
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04179253