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

NCT01224080 | Unknown Phase 2

• 1 other identifier: IVF-002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Observe implantation and clinical pregnancy rates post IVF

  1Year

Study Arms (1)

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.

Device: Adiana placement

Interventions

Adiana placement 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.

Adiana Device

Eligibility Criteria

• Age: 21 Years - 43 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reproductive Science Center: lead

Study Sites (1)

Reproductive Science Center

San Ramon, California, 94583, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 15, 2010
• First Posted: October 19, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2011
• Last Updated: October 19, 2010

Record last verified: 2010-10

Locations

US (1)