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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:Select...
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
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.
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.
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Who is running the clinical trial?
Reproductive Science CenterLead Sponsor
1 Previous Clinical Trials
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I want to receive treatment for my HS.I agree to have a special X-ray of my uterus and fallopian tubes 3 months after ADIANA placement.My uterus is significantly tilted backward.I have been diagnosed with conditions like fibroids or polyps inside my uterus.I am willing to participate in this clinical study.I gave birth or had a pregnancy termination less than 6 weeks ago.My overall or reproductive health is poor.I have cancer in my pelvic area.I currently have, or recently had, a pelvic infection.I understand and agree to participate in this study.
Research Study Groups:
This trial has the following groups:- Group 1: Adiana Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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