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

Infertility, Female Clinical Trial

Official title:

Hysteroscopic Evaluation of Uterine Cavity in Women With Unexplained Infertility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04179253
• Other study ID #: Beni-Suef 19
• Status: Completed
• Phase: N/A
• Start date: April 14, 2018
• Est. completion date: April 14, 2019

Study information

• Verified date: November 2019
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 14, 2019
• Est. primary completion date: April 14, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Normal HSG

• Normal Ultrasound

• Normal Hormonal Profile

• Normal Semen

Exclusion Criteria:

• Abnormal findings in different investigations of infertility

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

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.

Locations

Country	Name	City	State
Egypt	Beni-Suef University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. Review. — View 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. — View Citation

Molinas CR, Campo R. Office hysteroscopy and adenomyosis. Best Pract Res Clin Obstet Gynaecol. 2006 Aug;20(4):557-67. Epub 2006 Mar 22. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abnormal hysteroscopic findings	Description of different hysteroscopic abnormalities using micro-office hysteroscope	one year