What is the mechanism of action of this treatment?

Salpingectomy, the surgical removal of one or both fallopian tubes, is a common treatment for Tubal Occlusion, particularly in patients undergoing in vitro fertilization (IVF). The primary mechanism of action is the removal of the hydrosalpinx, a fluid-filled blocked fallopian tube, which can leak toxic fluid into the uterus, impairing embryo implantation and reducing IVF success rates. By removing the affected tube(s), salpingectomy prevents this fluid leakage, thereby improving the uterine environment and increasing the chances of successful implantation and pregnancy. This treatment is crucial for patients with Tubal Occlusion as it directly addresses the physical barrier and toxic environment caused by the hydrosalpinx, thereby enhancing fertility outcomes.

What side effects are associated with this type of intervention?

Salpingectomy, the surgical removal of the fallopian tube, is commonly performed to treat tubal occlusion and improve IVF outcomes. Known side effects include general surgical risks such as infection, bleeding, and damage to surrounding organs. Patients may also experience postoperative pain and the potential for adhesion formation, which can affect future fertility. These risks should be discussed with a healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved various treatments for tubal occlusion, with salpingectomy being a prominent surgical option. Salpingectomy involves the removal of one or both fallopian tubes to prevent fluid leakage and improve implantation rates, particularly in cases of hydrosalpinx. Non-surgical options include tubal occlusive devices like the Adiana system, which was used to block the fallopian tubes. However, the Adiana system was discontinued in 2012. These treatments aim to enhance fertility outcomes by addressing the underlying issues caused by tubal occlusion.

What other types of research exist?

One promising alternative to salpingectomy for tubal occlusion patients is the use of Adiana Tubal Occlusive Devices. This method involves placing a device in the fallopian tubes to block them, which can prevent fluid leakage and improve implantation rates without the need for surgical removal of the tubes.

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Tubal Occlusive Device

Adiana Placement for Tubal Occlusion

Phase 2

Waitlist Available

Research Sponsored by Reproductive Science Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

Severely retroverted uterus

Evidence of intrauterine abnormalities such as submucous fibroids, polyps, intrauterine adhesions or presence of a uterine septum

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1year

Awards & highlights

Summary

This trial focuses on women with hydrosalpinx, a condition where fluid blocks one or both fallopian tubes. The fluid can leak into the uterus and potentially harm the embryo or make implantation difficult.

Who is the study for?

This trial is for women who have been trying to get pregnant for over a year but can't because of blocked fallopian tubes filled with fluid (hydrosalpinx). They must be willing to undergo certain tests and not have any health issues like recent infections, severe uterus tilt, or allergies to nickel and contrast media. Their body mass index (BMI) should also be under 35.

What is being tested?

The study is testing the Adiana device, which aims to block the fallopian tubes in women with hydrosalpinx before they try in vitro fertilization. The goal is to see if stopping the harmful fluid from reaching the uterus improves their chances of getting pregnant.

What are the potential side effects?

Potential side effects may include discomfort during placement, allergic reactions especially in those sensitive to nickel, infection risks post-procedure, and possible impact on fertility if the device doesn't work as intended.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My uterus is significantly tilted backward.

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I have been diagnosed with conditions like fibroids or polyps inside my uterus.

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I gave birth or had a pregnancy termination less than 6 weeks ago.

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I have cancer in my pelvic area.

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I currently have, or recently had, a pelvic infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluate the success rate of proximal tubal occlusion with Adiana inserts in women with hydrosalpinx

Secondary study objectives

Observe implantation and clinical pregnancy rates post IVF

Trial Design

1Treatment groups

Experimental Treatment

Group I: Adiana DeviceExperimental Treatment1 Intervention

All patients will undergo the Adiana Tubal Occlusion procedure. This procedure will be done in an office based setting and last approximately 1 hour.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Salpingectomy, the surgical removal of one or both fallopian tubes, is a common treatment for Tubal Occlusion, particularly in patients undergoing in vitro fertilization (IVF). The primary mechanism of action is the removal of the hydrosalpinx, a fluid-filled blocked fallopian tube, which can leak toxic fluid into the uterus, impairing embryo implantation and reducing IVF success rates. By removing the affected tube(s), salpingectomy prevents this fluid leakage, thereby improving the uterine environment and increasing the chances of successful implantation and pregnancy. This treatment is crucial for patients with Tubal Occlusion as it directly addresses the physical barrier and toxic environment caused by the hydrosalpinx, thereby enhancing fertility outcomes.