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

Primary Purpose

Infertility, Female

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

office micro hysteroscopy

About this trial

This is an interventional diagnostic trial for Infertility, Female

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Normal HSG
Normal Ultrasound
Normal Hormonal Profile
Normal Semen

Exclusion Criteria:

Abnormal findings in different investigations of infertility

Sites / Locations

Beni-Suef University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Unexplained infertility

Arm Description

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.

Outcomes

Primary Outcome Measures

Abnormal hysteroscopic findings

Description of different hysteroscopic abnormalities using micro-office hysteroscope

Secondary Outcome Measures

Full Information

NCT ID

NCT04179253

First Posted

November 24, 2019

Last Updated

November 26, 2019

Sponsor

Beni-Suef University

1. Study Identification

Unique Protocol Identification Number

NCT04179253

Brief Title

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

Official Title

Hysteroscopic Evaluation of Uterine Cavity in Women With Unexplained Infertility

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

April 14, 2018 (Actual)

Primary Completion Date

April 14, 2019 (Actual)

Study Completion Date

April 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility, Female

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Unexplained infertility

Arm Type

Other

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

office micro hysteroscopy

Intervention Description

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 Outcome Measure Information:

Title

Abnormal hysteroscopic findings

Description

Description of different hysteroscopic abnormalities using micro-office hysteroscope

Time Frame

one year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Normal HSG Normal Ultrasound Normal Hormonal Profile Normal Semen Exclusion Criteria: Abnormal findings in different investigations of infertility

Facility Information:

Facility Name

Beni-Suef University

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

20576262

Citation

Cooper NA, Smith P, Khan KS, Clark TJ. A systematic review of the effect of the distension medium on pain during outpatient hysteroscopy. Fertil Steril. 2011 Jan;95(1):264-71. doi: 10.1016/j.fertnstert.2010.04.080. Epub 2010 Jun 23.

Results Reference

background

PubMed Identifier

16554185

Citation

Molinas CR, Campo R. Office hysteroscopy and adenomyosis. Best Pract Res Clin Obstet Gynaecol. 2006 Aug;20(4):557-67. doi: 10.1016/j.bpobgyn.2006.01.019. Epub 2006 Mar 22.

Results Reference

background

PubMed Identifier

24701493

Citation

Vaid K, Mehra S, Verma M, Jain S, Sharma A, Bhaskaran S. Pan endoscopic approach "hysterolaparoscopy" as an initial procedure in selected infertile women. J Clin Diagn Res. 2014 Feb;8(2):95-8. doi: 10.7860/JCDR/2014/7271.4018. Epub 2014 Feb 3.

Results Reference

background

PubMed Identifier

22592204

Citation

Kowalczyk D, Guzikowski W, Wiecek J, Sioma-Markowska U. Clinical value of real time 3D sonohysterography and 2D sonohysterography in comparison to hysteroscopy with subsequent histopathological examination in perimenopausal women with abnormal uterine bleeding. Neuro Endocrinol Lett. 2012;33(2):212-6.

Results Reference

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Learn more about this trial

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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