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

NCT ID: NCT04179253

Last Updated: 2019-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-14
• Study Completion Date: 2019-04-14

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.

Conditions

Infertility, Female

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

office micro hysteroscopy

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Abnormal findings in different investigations of infertility

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Nesreen Abdel Fattah Abdullah Shehata

Associate Professor in Obstetrics and Gynecology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beni-Suef University

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 20576262 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16554185 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24701493 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22592204 (View on PubMed)

Other Identifiers

Beni-Suef 19

Identifier Type: -

Identifier Source: org_study_id