Back to resultsLower Abdominal Pain During Office Hysteroscopy Can Assess Tubal Patency in Infertile Women
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
office hystroscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Infertility focused on measuring Office Hysteroscopy, tubal patency, infertility, Lower Abdominal Pain
Eligibility Criteria
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
Sites / Locations
- Kasr Alainy medical school
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
women with pain
women without pain
Arm Description
women who felt pain at time of office hystroscopy at time of saline infusion and for 15 minutes after end of procedure
women who didn't feel pain at time of office hystroscopy at time of saline infusion and for 15 minutes after end of procedure
Outcomes
Primary Outcome Measures
lower abdominal pain as measured by Visual Analog Scale
Pain, as measured by Visual Analog Scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02455635
Brief Title
Lower Abdominal Pain During Office Hysteroscopy Can Assess Tubal Patency in Infertile Women
Official Title
Lower Abdominal Pain During Office Hysteroscopy As A Guide In The Assessment Of Tubal Patency In Infertile Women
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Office Hysteroscopy, tubal patency, infertility, Lower Abdominal Pain
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
women with pain
Arm Type
Active Comparator
Arm Description
women who felt pain at time of office hystroscopy at time of saline infusion and for 15 minutes after end of procedure
Arm Title
women without pain
Arm Type
Active Comparator
Arm Description
women who didn't feel pain at time of office hystroscopy at time of saline infusion and for 15 minutes after end of procedure
Intervention Type
Procedure
Intervention Name(s)
office hystroscopy
Intervention Description
Office hysteroscopythrough 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
Primary Outcome Measure Information:
Title
lower abdominal pain as measured by Visual Analog Scale
Description
Pain, as measured by Visual Analog Scale
Time Frame
at time of hystroscopy till 15 minutes after end of procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged
Organizational Affiliation
Kasr Alainy medical school
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12151
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Lower Abdominal Pain During Office Hysteroscopy Can Assess Tubal Patency in Infertile Women
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