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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01224080
Recruitment Status : Unknown
Verified October 2010 by Reproductive Science Center.
Recruitment status was:  Recruiting
First Posted : October 19, 2010
Last Update Posted : October 19, 2010
Information provided by:
Reproductive Science Center

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2010
Estimated Primary Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tubal Ligation

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Observe implantation and clinical pregnancy rates post IVF [ Time Frame: 1Year ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01224080

United States, California
Reproductive Science Center Recruiting
San Ramon, California, United States, 94583
Contact: Jennifer McWatters    925-973-5012   
Principal Investigator: Donald Galen, M.D.         
Sponsors and Collaborators
Reproductive Science Center

Responsible Party: Donald Galen M.D., Reproductive Science Center Identifier: NCT01224080     History of Changes
Other Study ID Numbers: IVF-002
First Posted: October 19, 2010    Key Record Dates
Last Update Posted: October 19, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms