Lower Abdominal Pain During Office Hysteroscopy Can Assess Tubal Patency in Infertile Women

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT02455635

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Procedure: office hystroscopy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Lower Abdominal Pain During Office Hysteroscopy As A Guide In The Assessment Of Tubal Patency In Infertile Women

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: women with pain women who felt pain at time of office hystroscopy at time of saline infusion and for 15 minutes after end of procedure	Procedure: office hystroscopy 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
Active Comparator: women without pain women who didn't feel pain at time of office hystroscopy at time of saline infusion and for 15 minutes after end of procedure	Procedure: office hystroscopy 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

Arm

Intervention/Treatment

Active Comparator: women with pain

women who felt pain at time of office hystroscopy at time of saline infusion and for 15 minutes after end of procedure

Procedure: office hystroscopy

Active Comparator: women without pain

women who didn't feel pain at time of office hystroscopy at time of saline infusion and for 15 minutes after end of procedure

Procedure: office hystroscopy

Outcome Measures

Primary Outcome Measures

lower abdominal pain as measured by Visual Analog Scale [at time of hystroscopy till 15 minutes after end of procedure]
Pain, as measured by Visual Analog Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 30 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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