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

NCT ID: NCT01224080

Last Updated: 2010-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Adiana placement

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Reproductive Science Center

INDUSTRY

Sponsor Role: lead

Responsible Party

Reproductive Science Center

Locations

Reproductive Science Center

San Ramon, California, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Jennifer McWatters

Role: primary

jennifer.mcwatters@integramed.com

925-973-5012

Other Identifiers

IVF-002

Identifier Type: -

Identifier Source: org_study_id