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

Ain Shams University

Status and phase: Not yet enrolling; Phase 3

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

Treatments: Drug: iso-amyl- 2-cyanoacrylate.; Drug: iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil

Study type: Interventional

Funder types: Other

Identifiers

NCT06130072

ASU124

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 estimated patients

Sex: Female

Ages: 25 to 43 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups

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

Active Comparator group

Description:

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

Treatment:

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

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

Active Comparator group

Description:

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

Treatment:

Drug: iso-amyl- 2-cyanoacrylate.