Effectiveness of Isoamyl-2-cyanoacrylate With and Without Ethiodized Oil in Occluding Hydrosalpinx Prior to IVFPhase 3NCT06130072

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

A Phase 3 study testing iso-amyl- 2-cyanoacrylate. and iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil in people with Effectiveness of Isoamyl-2-cyanoacrylate With and Without Ethiodized Oil in Occluding Hydrosalpinx Prior to IVF, run by Ain Shams University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

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

Who is it for?: Ages 25 to 43 years, women onlyHealthy volunteers can take part
Conditions the study is for: Effectiveness of Isoamyl-2-cyanoacrylate With and Without Ethiodized Oil in Occluding Hydrosalpinx Prior to IVF
What is being tested?: iso-amyl- 2-cyanoacrylate. and iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: No sites listed yet
Study dates: 10 Nov 2023to 10 Mar 2024
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 43 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

None listed.

Who cannot join

• 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.

About this study

Official title: Hysteroscopic Tubal Occlusion Using Iso-amyl- 2-cyanoacrylate With or Without Ethiodized Oil (Lipidol) in Patients With Hydrosalpinx Prior to IVF

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

Read the 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.

Conditions: Effectiveness of Isoamyl-2-cyanoacrylate With and Without Ethiodized Oil in Occluding Hydrosalpinx Prior to IVF
Being tested: iso-amyl- 2-cyanoacrylate., iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

iso-amyl- 2-cyanoacrylate.Drug
Hysteroscopic tubal occlusion using iso-amyl- 2-cyanoacrylate in patients with hydrosalpinx prior to IVF
iso-amyl- 2-cyanoacrylate mixed with Ethiodized oilDrug
iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil (Lipidol)

Study groups in NCT06130072
Study group	Role	What they receive
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. Receives: 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 . Receives: Drug: iso-amyl- 2-cyanoacrylate.

What is being measured

The primary outcome is the main question the study is designed to answer.

Fallopian tube occlusion
hysteosaplingographic diagnosis of tubal occlusion
Measured: one to three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Nov 202310 Mar 2024

First posted13 Nov 2023
Study start10 Nov 2023 (estimated)
Primary completion10 Mar 2024 (estimated)
Study completion10 Mar 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Effectiveness of Isoamyl-2-cyanoacrylate With and Without Ethiodized Oil in Occluding Hydrosalpinx Prior to IVFStudies of the same condition, open and under way.
More trials run by Ain Shams UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: Hysteroscopic tubal occlusion using iso-amyl- 2-cyanoacrylate with or without Ethiodized oil (Lipidol) in patients with hydrosalpinx prior to IVF
Masking: Single blind
Who is masked: Participant
Enrolment: 45 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06130072
Sponsor's protocol ID: ASU124
Status last verified: Oct 2023
First submitted: 28 Oct 2023
Last updated: 13 Nov 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hysteroscopic Tubal Occlusion Using Iso-amyl- 2-cyanoacrylate With or Without Ethiodized Oil (Lipidol) in Patients With Hydrosalpinx Prior to IVF
ClinicalTrials.gov ID: NCT06130072
Acronym / sponsor ID: ASU124
Conditions: Effectiveness of Isoamyl-2-cyanoacrylate With and Without Ethiodized Oil in Occluding Hydrosalpinx Prior to IVF
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 45 participants (estimated)
Lead sponsor: Ain Shams UniversityUniversity, hospital or other
Study start: 10 Nov 2023 (estimated)
Primary completion: 10 Mar 2024 (estimated)
Study completion: 10 Mar 2024 (estimated)
First posted: 13 Nov 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Hysteroscopic tubal occlusion using iso-amyl- 2-cyanoacrylate with or without Ethiodized oil (Lipidol) in patients with hydrosalpinx prior to IVF

Arm	Type	Receives
Hysteroscopic tubal occlusion using iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil	Active comparator	Drug: iso-amyl- 2-cyanoacrylate mixed with Ethiodized oilGroup 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	Active comparator	Drug: iso-amyl- 2-cyanoacrylate.Group 1 including 25 patients with hydrosalpinx refaired for hysteroscopic tubal occlusion prior to IVF using iso-amyl- 2-cyanoacrylate .

Who may qualify

Ages: 25 to 43 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (0 listed)

Key exclusion criteria (4 listed)

• Any patient with acute pelvic inflammatory disease, endometritis, lower genital tract infection.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
iso-amyl- 2-cyanoacrylate.Hysteroscopic tubal occlusion using iso-amyl- 2-cyanoacrylate in patients with hydrosalpinx prior to IVF	Drug	Hysteroscopic tubal occlusion using only iso-amyl- 2-cyanoacrylate
iso-amyl- 2-cyanoacrylate mixed with Ethiodized oiliso-amyl- 2-cyanoacrylate mixed with Ethiodized oil (Lipidol)	Drug	Hysteroscopic tubal occlusion using iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil

Primary outcome

Fallopian tube occlusion
Time frame: one to three months
hysteosaplingographic diagnosis of tubal occlusion

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fallopian tube occlusion (time frame: one to three months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06130072.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.