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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02455635
Other study ID # 135
Secondary ID
Status Completed
Phase N/A
First received May 21, 2015
Last updated March 18, 2017
Start date January 2013
Est. completion date September 2016

Study information

Verified date March 2017
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Office hysteroscopy through vaginoscopic approach was done in gynecology out-patient clinic with saline distension medium. The presence or absence of lower abdominal pain and the side of pain were recorded. Then, transvaginal sonography within 20 minutes was done to detect the presence of free fluid in the pouch of Douglas. Then, laparoscopy with tubal chromopertubation was done.


Description:

Office hysteroscopy through vaginoscopic approach was done in gynecology out-patient clinic using a 4 mm endoscopic sheath & 30 ᵒ endoscopic camera with saline distension medium using 90-100 mmHg pressure. Meanwhile, the presence or absence of lower abdominal pain and the side of pain were recorded. Then, transvaginal sonography within 20 minutes was done to detect the presence of free fluid in the pouch of Douglas.Then, laparoscopy with tubal chromopertubation was done.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 30 Years
Eligibility Inclusion Criteria:

- Infertile women normal semen analysis

Exclusion Criteria:

- Ladies with evidence of upper or lower genital tract infections,

- presence of free fluid in the pouch of Douglas before hysteroscopy or pelvic pathology or those with cervical stenosis that required cervical dilatation prior to hysteroscopy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
office hystroscopy
Office hysteroscopythrough vaginoscopic approach was done in gynecology out-patient clinic using a 4 mm endoscopic sheath & 30 ? endoscopic camera with saline distension medium using 90-100 mmHg pressure

Locations

Country Name City State
Egypt Kasr Alainy medical school Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary lower abdominal pain as measured by Visual Analog Scale Pain, as measured by Visual Analog Scale at time of hystroscopy till 15 minutes after end of procedure
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