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

Phase 3

Not yet recruiting

• Conditions: Effectiveness of Isoamyl-2-cyanoacrylate With and Without Ethiodized Oil in Occluding Hydrosalpinx Prior to IVF
• Interventions: Drug: iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil; Drug: iso-amyl- 2-cyanoacrylate.

• Registration Number: NCT06130072
• Lead Sponsor: Ain Shams University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-28
• Study Start: 2023-11-10
• Study First Submitted QC: 2023-11-11
• Last Update Submitted: 2023-11-11
• Study First Posted: 2023-11-13
• Last Update Posted: 2023-11-13
• Primary Completion: 2024-03-10
• Study Completion: 2024-03-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hysteroscopic tubal occlusion using iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil	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.
Hysteroscopic tubal occlusion using only iso-amyl- 2-cyanoacrylate	iso-amyl- 2-cyanoacrylate.	Group 1 including 25 patients with hydrosalpinx refaired for hysteroscopic tubal occlusion prior to IVF using iso-amyl- 2-cyanoacrylate .

Primary Outcome Measures

Name	Time	Method
Fallopian tube occlusion	one to three months	hysteosaplingographic diagnosis of tubal occlusion