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

NCT ID: NCT02455635

Last Updated: 2017-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Infertility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

office hystroscopy

Intervention Type PROCEDURE

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

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

Group Type ACTIVE_COMPARATOR

office hystroscopy

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Maged

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Maged

Role: PRINCIPAL_INVESTIGATOR

Kasr Alainy medical school

Locations

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Kasr Alainy medical school

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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135

Identifier Type: -

Identifier Source: org_study_id

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