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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

B

Beni-Suef University

Status

Completed

Conditions

Infertility, Female

Treatments

Diagnostic Test: office micro hysteroscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT04179253
Beni-Suef 19

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Abnormal findings in different investigations of infertility

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Unexplained infertility
Other group
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.
Treatment:
Diagnostic Test: office micro hysteroscopy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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