NCT02977234

Brief Summary

The purpose of this study is to assess the effectiveness of hysteroscopic tubal application of Iso Amyl-2-cyanoacrylate in occluding uterine tubes of infertile women with hydrosalpinx, which would make it an easy approach for occluding tubes with hydrosalpinx prior to IVF.

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
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

December 27, 2017

Status Verified

December 1, 2017

Enrollment Period

1.3 years

First QC Date

November 23, 2016

Last Update Submit

December 25, 2017

Conditions

HydrosalpinxInfertility, Female

Outcome Measures

Primary Outcomes (1)

  • Fallopian tubal occlusion in patients with hydrosalpinx.

    from one to three months

Study Arms (1)

Iso-Amyl 2-Cyano Acrylate

EXPERIMENTAL

Hysteroscopic Tubal Occlusion Using Iso-Amyl 2-Cyano Acrylate (Amcrylate) in Patients With Hydrosalpinx

Drug: Isoamyl 2-Cyanoacrylate

Interventions

Isoamyl 2-CyanoacrylateDRUG
Iso-Amyl 2-Cyano Acrylate

Eligibility Criteria

Age22 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Infertile women due to tubal factor with hydrosalpinx (unilateral or bilateral) prepared for IVF.

You may not qualify if:

  • Acute Pelvic inflammatory disease.
  • Intra uterine pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIn Shams University Maternity Hospital

Cairo, 11357, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Interventions

isoamyl 2-cyanoacrylate

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Officials

  • Mohamed I Amer, MD

    Ain Shams University maternity hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed I Amer, MD

CONTACT

oo2o1oo1519370mohamed_amer810@yahoo.com

Study Design

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

Study Record Dates

First Submitted

November 23, 2016

First Posted

November 30, 2016

Study Start

October 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

December 27, 2017

Record last verified: 2017-12

Locations

EG(1)