NCT06130072

Brief Summary

Hysteroscopic tubal occlusion using iso-amyl- 2-cyanoacrylate with or without Ethiodized oil (Lipidol) in patients with hydrosalpinx prior to IVF

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2023

Shorter than P25 for phase_3

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

First Submitted

Initial submission to the registry

October 28, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

November 10, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2024

Completed
Last Updated

November 13, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

October 28, 2023

Last Update Submit

November 11, 2023

Conditions

Effectiveness of Isoamyl-2-cyanoacrylate With and Without Ethiodized Oil in Occluding Hydrosalpinx Prior to IVF

Outcome Measures

Primary Outcomes (1)

  • Fallopian tube occlusion

    hysteosaplingographic diagnosis of tubal occlusion

    one to three months

Study Arms (2)

Hysteroscopic tubal occlusion using iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil

ACTIVE COMPARATOR

Group 2 including 20 patients with hydrosalpinx refaired for hysteroscopic tubal occlusion prior to IVF using iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil.

Drug: iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil

Hysteroscopic tubal occlusion using only iso-amyl- 2-cyanoacrylate

ACTIVE COMPARATOR

Group 1 including 25 patients with hydrosalpinx refaired for hysteroscopic tubal occlusion prior to IVF using iso-amyl- 2-cyanoacrylate .

Drug: iso-amyl- 2-cyanoacrylate.

Interventions

iso-amyl- 2-cyanoacrylate.DRUG

Hysteroscopic tubal occlusion using iso-amyl- 2-cyanoacrylate in patients with hydrosalpinx prior to IVF

Hysteroscopic tubal occlusion using only iso-amyl- 2-cyanoacrylate
iso-amyl- 2-cyanoacrylate mixed with Ethiodized oilDRUG

iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil (Lipidol)

Hysteroscopic tubal occlusion using iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil

Eligibility Criteria

Age25 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Any patient with acute pelvic inflammatory disease, endometritis, lower genital tract infection.
  • The presence of intrauterine synechiae that might hinder the proper hysteroscopic examination and tubal cannulation diagnosed by diagnostic hysteroscopy.
  • The presence of uterine anomalies that might hinder the proper hysteroscopic examination and tubal cannulation diagnosed by diagnostic hysteroscopy.
  • Undiagnosed genital bleeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Ethiodized Oil

Intervention Hierarchy (Ancestors)

Iodized OilPlant OilsOilsLipidsPlant PreparationsBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Hysteroscopic tubal occlusion using iso-amyl- 2-cyanoacrylate with or without Ethiodized oil (Lipidol) in patients with hydrosalpinx prior to IVF
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 28, 2023

First Posted

November 13, 2023

Study Start

November 10, 2023

Primary Completion

March 10, 2024

Study Completion

March 10, 2024

Last Updated

November 13, 2023

Record last verified: 2023-10