Women Suffering From Unilateral or Bilateral Tubal Occlusion Due to HydrosalpinxPhase 2NCT01224080
Use of Adiana Tubal Occlusive Devices in Women With Hydrosalpinx Prior to In Vitro Fertilization
A Phase 2 study testing Adiana placement in people with Women Suffering From Unilateral or Bilateral Tubal Occlusion Due to Hydrosalpinx, run by Reproductive Science Center at 1 site in United States.
Trial summary
A condition called hydrosalpinx occurs when one or both of the fallopian tubes is blocked with fluid. The fluid can leak into the tube and the uterus. The theory is that the fluid can harm the tubes and uterus making implantation more difficult or harm the embryo. Read more about this study
- Who is it for?
- Ages 21 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women Suffering From Unilateral or Bilateral Tubal Occlusion Due to Hydrosalpinx
- What is being tested?
- Adiana placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Oct 2011
- Phase
- Phase 2
- 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 21 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are willing to participate in this clinical study
- Are able to comprehend and give informed consent for participation in this study
- Have read, understood and signed an informed consent form
- Have been unable to achieve pregnancy after trying for 1 year or greater and who have unilateral or bilateral hydrosalpinges as evidenced by laparoscopy or ultrasound or HSG
- Have a Day #3 serum FSH<10, and Day #3 Estradiol<80
- Recipient women undergoing a ovum donor cycle the donor must have a Day 3 serum FSH < 10 and Day 3 Estradiol < 80
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- Have an antral follicle count 10 or greater for both ovaries combined, if women using ovum donor (follicle count) will be based on eligible donor
- 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
Who cannot join
- Active or recent upper or lower pelvic infection
- Known hypersensitivity to nickel as confirmed by skin test
- Known allergy to contrast media
- Pregnancy or suspected pregnancy
- Delivery or termination of pregnancy less than six weeks prior to Adiana placements
- BMI > 35
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- Abnormal pap smear (CIN2 or greater abnormality) within the past year
- Pelvic malignancy
- Severely retroverted uterus
- Evidence of intrauterine abnormalities such as submucous fibroids, polyps, intrauterine adhesions or presence of a uterine septum
- Abnormal Clomid Challenge Test or abnormal lab values on Day #3 serum FSH and Estradiol
- Antral follicle count less than 10 (both ovaries combined)
- Poor general or gynecologic health
- Inability or refusal to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Reproductive Science Center
San Ramon, California, 94583
Jennifer McWatters, 925-973-5012, jennifer.mcwatters@integramed.com
Donald Galen, M.D.
About this study
A condition called hydrosalpinx occurs when one or both of the fallopian tubes is blocked with fluid. The fluid can leak into the tube and the uterus. The theory is that the fluid can harm the tubes and uterus making implantation more difficult or harm the embryo.
- Being tested
- Adiana placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adiana placementDevice
All patients will undergo the Adiana Tubal Occlusion procedure. This procedure will be done in an office based setting and last approximately 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Adiana Device | Experimental | All patients will undergo the Adiana Tubal Occlusion procedure. This procedure will be done in an office based setting and last approximately 1 hour. Receives: Device: Adiana placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the success rate of proximal tubal occlusion with Adiana inserts in women with hydrosalpinx
Analysis of results will be performed on the intent-to-treat population defined as all subjects in whom device placement was attempted and on the per protocol population defined as all subjects who had successful placement of the Adiana occlusion device and were followed for a minimum of one year post HSG confirmation test.
Measured: 1 Year
Secondary outcomes (1)
Observe implantation and clinical pregnancy rates post IVF
Factors affecting the placement rate, tubal occlusion rate, and clinical pregnancy rate will be reviewed. This study employs an unblended, non randomized, single group design, in which subjects serve as their own controls. Because this feasibility study will enroll a maximum of ten (10) subjects, it is not designed with success/failure benchmarks, nor is it statistically powered to make any claims regarding effectiveness of hysteroscopic proximal tubal occlusion in women with hydrosalpinx who are planning to undergo IVF.
Measured: 1Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women Suffering From Unilateral or Bilateral Tubal Occlusion Due to HydrosalpinxStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reproductive Science Center
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224080
- Sponsor's protocol ID
- IVF-002
- Status last verified
- Oct 2010
- First submitted
- 15 Oct 2010
- Last updated
- 19 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Adiana Tubal Occlusive Devices in Women With Hydrosalpinx Prior to In Vitro Fertilization
- ClinicalTrials.gov ID
- NCT01224080
- Acronym / sponsor ID
- IVF-002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Reproductive Science CenterIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Oct 2011 (estimated)
- First posted
- 19 Oct 2010 (estimated)
- 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.
A condition called hydrosalpinx occurs when one or both of the fallopian tubes is blocked with fluid. The fluid can leak into the tube and the uterus. The theory is that the fluid can harm the tubes and uterus making implantation more difficult or harm the embryo.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adiana Device | Experimental | Device: Adiana placementAll patients will undergo the Adiana Tubal Occlusion procedure. This procedure will be done in an office based setting and last approximately 1 hour. |
Who may qualify
- Ages
- 21 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Are willing to participate in this clinical study
- Are able to comprehend and give informed consent for participation in this study
- Have read, understood and signed an informed consent form
- Have been unable to achieve pregnancy after trying for 1 year or greater and who have unilateral or bilateral hydrosalpinges as evidenced by laparoscopy or ultrasound or HSG
- Have a Day #3 serum FSH<10, and Day #3 Estradiol<80
Key exclusion criteria (14 listed)
- Active or recent upper or lower pelvic infection
- Known hypersensitivity to nickel as confirmed by skin test
- Known allergy to contrast media
- Pregnancy or suspected pregnancy
- Delivery or termination of pregnancy less than six weeks prior to Adiana placements
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 |
|---|---|---|
| Adiana placementAll patients will undergo the Adiana Tubal Occlusion procedure. This procedure will be done in an office based setting and last approximately 1 hour. | Device | Adiana Device |
Primary outcome
Evaluate the success rate of proximal tubal occlusion with Adiana inserts in women with hydrosalpinx
Time frame: 1 Year
Analysis of results will be performed on the intent-to-treat population defined as all subjects in whom device placement was attempted and on the per protocol population defined as all subjects who had successful placement of the Adiana occlusion device and were followed for a minimum of one year post HSG confirmation test.
1 secondary outcome
Observe implantation and clinical pregnancy rates post IVF
Time frame: 1Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2010.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adiana placement in people with Women Suffering From Unilateral or Bilateral Tubal Occlusion Due to Hydrosalpinx, run by Reproductive Science Center at 1 site in United States.
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 9 inclusion and 14 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 19 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the success rate of proximal tubal occlusion with Adiana inserts in women with hydrosalpinx (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2010.