NCT02455635

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

3.7 years

First QC Date

May 21, 2015

Last Update Submit

March 18, 2017

Conditions

Infertility

Keywords

Office Hysteroscopytubal patencyinfertilityLower Abdominal Pain

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

women with pain

ACTIVE COMPARATOR

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

women without pain

ACTIVE COMPARATOR

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

Interventions

office hystroscopyPROCEDURE

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 with painwomen without pain

Eligibility Criteria

Age20 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Infertile women normal semen analysis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, Cairo Governorate, 12151, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Ahmed Maged

    Kasr Alainy medical school

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 21, 2015

First Posted

May 28, 2015

Study Start

January 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

March 21, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

Locations

EG(1)