NCT02698644

Brief Summary

Is to assess the effectiveness of hysteroscopic tubal application of Iso Amyl-2-cyanoacrylate in occluding uterine tubes of women, which would make it an easy approach for occluding tubes with hydrosalpinx prior to IVF and in tubal sterilization.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

March 4, 2016

Status Verified

February 1, 2016

Enrollment Period

6 months

First QC Date

February 19, 2016

Last Update Submit

February 29, 2016

Conditions

Fallopian Tube Occlusion

Outcome Measures

Primary Outcomes (1)

  • fallopian tube obstruction

    assessed by failure of passage of methylene blue through fallopian tubes after injecting it transcervical in the hysterectomy spacements.

    from one day to four weeks

Secondary Outcomes (1)

  • degree and extend of inflammation in the fallopian tubes

    from one day to four weeks

Study Arms (1)

isoamyl2cyanoacrylate

EXPERIMENTAL

Isoamyl-2-cyanoacrylate will be injected inside fallopian tube hysteroscopically through ureteric catheter

Drug: Isoamyl-2-cyanoacrylate

Interventions

Isoamyl-2-cyanoacrylateDRUG

Isoamyl-2-cyanoacrylate will be injected inside fallopian tube hysteroscopically through ureteric catheter

Also known as: AMCRYLATE®
isoamyl2cyanoacrylate

Eligibility Criteria

Age40 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients planned for abdominal hysterectomy with well seen tubal ostia through hysteroscope

You may not qualify if:

  • Any patient with Upper or lower genital tract infection as evidenced by fever, lower abdominal pain or tenderness and abnormal vaginal discharge will be excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIn Shams University Maternity Hospital

Cairo, Cairo Governorate, 11357, Egypt

RECRUITING

Study Officials

  • Mohamed I Amer, MD

    Ain Shams University maternity hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed I Amer, MD

CONTACT

00201001519370mohamed_amer810@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 19, 2016

First Posted

March 4, 2016

Study Start

January 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

March 4, 2016

Record last verified: 2016-02

Locations

EG(1)