Recruiting
Phase 2

Adiana Devices

Sponsor:

Reproductive Science Center

Code:

NCT01224080

Conditions

Women Suffering From Unilateral or Bilateral Tubal Occlusion Due to Hydrosalpinx

Eligibility Criteria

Sex: Female

Age: 21 - 43

Healthy Volunteers: Accepted

Interventions

Adiana placement

Study Details

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.

Conditions

Women Suffering From Unilateral or Bilateral Tubal Occlusion Due to Hydrosalpinx

Study ID

NCT01224080

Start date

Oct, 2010

Status verified date

Oct, 2010

Primary completion date

Oct, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 43

Healthy Volunteers: Accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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 measure

  • Evaluate the success rate of proximal tubal occlusion with Adiana inserts in women with hydrosalpinx [ Time Frame: 1 Year ]

Central Contacts and Locations

Locations

Reproductive Science Center

Recruiting

San Ramon, California, United States, 94583

Contacts

Jennifer McWatters

925-973-5012jennifer.mcwatters@integramed.com

Principal Investigator:

Donald Galen, M.D.

More Information

Sponsor

Reproductive Science Center

Last update posted

Oct 19, 2010

Last verified

Oct, 2010

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Reproductive Science Center on 2010-10-19.