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

Sponsor

Beni-Suef University (Other)

Overall Status

Completed

CT.gov ID

NCT04179253

Collaborator

(none)

100

Enrollment

Location

Arm

Actual Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female	Diagnostic Test: office micro hysteroscopy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

One hundred women with unexplained infertility recruited for office micro hysteroscopic sessionOne hundred women with unexplained infertility recruited for office micro hysteroscopic session

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Hysteroscopic Evaluation of Uterine Cavity in Women With Unexplained Infertility

Actual Study Start Date :

Apr 14, 2018

Actual Primary Completion Date :

Apr 14, 2019

Actual Study Completion Date :

Apr 14, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Unexplained infertility 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.

Arm

Intervention/Treatment

Other: Unexplained infertility

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.

Outcome Measures

Primary Outcome Measures

Abnormal hysteroscopic findings [one year]
Description of different hysteroscopic abnormalities using micro-office hysteroscope

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Normal HSG
Normal Ultrasound
Normal Hormonal Profile
Normal Semen

Exclusion Criteria:

Abnormal findings in different investigations of infertility

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beni-Suef University	Cairo		Egypt

Sponsors and Collaborators

Beni-Suef University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Nesreen Abdel Fattah Abdullah Shehata, Associate Professor in Obstetrics and Gynecology Department, Beni-Suef University

ClinicalTrials.gov Identifier:

NCT04179253

Other Study ID Numbers:

Beni-Suef 19

First Posted:

Nov 27, 2019

Last Update Posted:

Nov 27, 2019

Last Verified:

Nov 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infertility

Infertility, Female

Study Results

No Results Posted as of Nov 27, 2019