NCT02710305

Brief Summary

hysterosalpingography is a diagnosis procedure in the evaluation of infertile women and considered to be the traditional and the gold standard in the assessment of the patency of the fallopian tubes. The major disadvantage of hysterosalpingography is pain. In a study reported the patients complained of moderate to severe pain during the procedure. It is reported that some patients undergoing hysterosalpingography was more stressful and anxiety and effect on pain scores.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

March 11, 2016

Last Update Submit

January 8, 2017

Conditions

Pain Relief

Outcome Measures

Primary Outcomes (1)

  • Mean pain score during HSG

    intraoperative

Secondary Outcomes (2)

  • Mean pain score after HSG

    30 minutes

  • rate of side effects

    30 minutes

Study Arms (2)

Group A

ACTIVE COMPARATOR

oral hyoscine butyl bromide tablets plus lidocaine cream

Drug: oral hyoscine butyl bromide tablets plus lidocaine cream

Group B

PLACEBO COMPARATOR

oral placebo tablets plus placebo cream

Drug: oral placebo tablets plus placebo cream

Interventions

oral hyoscine butyl bromide tablets plus lidocaine creamDRUG

patients will take oral hyoscine butyl bromide 30 minutes before the procedure plus lidocaine anesthetic cream placed into their cervix immediately before the procedure

Group A
oral placebo tablets plus placebo creamDRUG

patients will take oral placebo 30 minutes before the procedure plus placebo cream placed into their cervix immediately before the procedure

Group B

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The infertile women who indicated for HSG

You may not qualify if:

  • contraindications to Hyoscine or lidocaine
  • known sensitivity to contrast media
  • abnormal uterine bleeding
  • genital tract infection
  • suspected pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 11, 2016

First Posted

March 16, 2016

Study Start

April 1, 2016

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

January 10, 2017

Record last verified: 2017-01

Locations

EG(1)