Hysteroscopic Tubal Occlusion Using Amacrylate With or Without Lipidol in Patients With Hydrosalpinx Prior to IVF

NCT ID: NCT06130072

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-10

Study Completion Date

2024-03-10

Brief Summary

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

Detailed Description

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hysteroscopic injection of iso-amyl- 2-cyanoacrylate with or without Ethiodized oil (Lipidol) in patients with hydrosalpinx requiring IVF. after one months and two months of the primary injection hysterosalpingography will be done to test for tubal occlusion.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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

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

Group Type ACTIVE_COMPARATOR

iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil

Intervention Type DRUG

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

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

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

Group Type ACTIVE_COMPARATOR

iso-amyl- 2-cyanoacrylate.

Intervention Type DRUG

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

Interventions

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iso-amyl- 2-cyanoacrylate.

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

Intervention Type DRUG

iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil

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

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* • 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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed I Amer

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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ASU124

Identifier Type: -

Identifier Source: org_study_id

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