Use of Adiana Tubal Occlusive Devices in Women With Hydrosalpinx Prior to In Vitro Fertilization

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Reproductive Science Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Reproductive Science Center
ClinicalTrials.gov Identifier:
NCT01224080
First received: October 15, 2010
Last updated: October 18, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Women Suffering From Unilateral or Bilateral Tubal Occlusion Due to Hydrosalpinx
Device: Adiana placement
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Reproductive Science Center:

Primary Outcome Measures:
  • Evaluate the success rate of proximal tubal occlusion with Adiana inserts in women with hydrosalpinx [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Observe implantation and clinical pregnancy rates post IVF [ Time Frame: 1Year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 10
Study Start Date: October 2010
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adiana Device
All 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 placement
All patients will undergo the Adiana Tubal Occlusion procedure. This procedure will be done in an office based setting and last approximately 1 hour.

  Eligibility

Ages Eligible for Study:   21 Years to 43 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224080

Locations
United States, California
Reproductive Science Center Recruiting
San Ramon, California, United States, 94583
Contact: Jennifer McWatters    925-973-5012    jennifer.mcwatters@integramed.com   
Principal Investigator: Donald Galen, M.D.         
Sponsors and Collaborators
Reproductive Science Center
  More Information

No publications provided

Responsible Party: Donald Galen M.D., Reproductive Science Center
ClinicalTrials.gov Identifier: NCT01224080     History of Changes
Other Study ID Numbers: IVF-002
Study First Received: October 15, 2010
Last Updated: October 18, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Salpingitis
Stress, Psychological
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Pelvic Inflammatory Disease
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 20, 2014