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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
Have a desire to receive treatment for their HS
Are willing to undergo a hysterosalpingogram (HSG) 3 months after ADIANA placement to confirm proximal tubal occlusion
Must not have
Be younger than 18 years old
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up1year
Awards & highlights
No Placebo-Only Group

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.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You want to get treatment for your HS (hidradenitis suppurativa).
Select...
You agree to have a special X-ray test called a hysterosalpingogram (HSG) done 3 months after the ADIANA procedure to make sure the tubes are blocked properly.

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a site

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.
~1 spots leftby Sep 2024
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