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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1year
Awards & highlights

Study Summary

This trial is testing whether a surgery to remove the fallopian tube(s) with hydrosalpinx improves the chance for a live birth in women who have had prior IVF cycles.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate the success rate of proximal tubal occlusion with Adiana inserts in women with hydrosalpinx
Secondary outcome measures
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.

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Who is running the clinical trial?

Reproductive Science CenterLead Sponsor
1 Previous Clinical Trials

Media Library

Adiana (Tubal Occlusive Device) Clinical Trial Eligibility Overview. Trial Name: NCT01224080 — Phase 2
Tubal Occlusion Research Study Groups: Adiana Device
Tubal Occlusion Clinical Trial 2023: Adiana Highlights & Side Effects. Trial Name: NCT01224080 — Phase 2
Adiana (Tubal Occlusive Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01224080 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA support the use of Adiana for contraception?

"While there is some data supporting Adiana's safety, as this is only a Phase 2 trial, Power rates it a 2."

Answered by AI

Are there any limitations on who can participate in this research?

"The prerequisites for this study are that applicants must experience stress, have psychological difficulties, and be between 21 and 43 years old. So far, the study has admitted 10 people."

Answered by AI

Does this research require all participants to be middle-aged?

"According to the age requirements for this trial, patients must be between 21 and 43 years old in order to qualify."

Answered by AI

Are new enrollees still being taken for this research project?

"This study, which was originally posted on October 1st 2010, is not looking for any more participants at the moment. Although this particular trial is no longer active, there are 111 other studies that are currently enrolling patients."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Reproductive Science Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Use of Adiana Tubal Occlusive Devices in Women With Hydrosalpinx Prior to In Vitro Fertilization
2010. "Use of Adiana Tubal Occlusive Devices in Women With Hydrosalpinx Prior to In Vitro Fertilization". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01224080.
All > Osa > Paid Studies California
~1 spots leftby Apr 2025
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