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

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 Overview

• Status: Unknown
• Conditions: Women Suffering From Unilateral or Bilateral Tubal Occlusion Due to Hydrosalpinx
• Intervention / Treatment: Device: Adiana placement

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Ramon, California, United States, 94583
      • Recruiting
      • Reproductive Science Center
      • Contact: Jennifer McWatters; Phone Number: 925-973-5012; Email: jennifer.mcwatters@integramed.com
      • Principal Investigator: Donald Galen, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1Year

Collaborators and Investigators

• Sponsor: Reproductive Science Center

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): October 1, 2011

Study Registration Dates

• First Submitted: October 15, 2010
• First Submitted That Met QC Criteria: October 18, 2010
• First Posted (Estimate): October 19, 2010

Study Record Updates

• Last Update Posted (Estimate): October 19, 2010
• Last Update Submitted That Met QC Criteria: October 18, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: IVF-002