Use of Essure® Micro-inserts in Women With Hydrosalpinx Prior to In Vitro Fertilization: A Prospective, Multicenter, International Feasibility Study

The purpose of this study is to gather safety data related to the use of Essure® micro-inserts in women with hydrosalpinx prior to in vitro fertilization and during pregnancy and to collect data with regard to implantation rates, clinical pregnancy rates, and pregnancy outcomes.

Study Overview

• Status: Completed
• Conditions: Women Who Suffer From Hydrosalpinx That is Causing Infertility and Whom Want a Safer Way of Treamtent
• Intervention / Treatment: Device: Essure Micro Insert

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Ramon, California, United States, 94583
      • Reproductive Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 38 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

Women age 21-38 (unless women in ovum donor cycle then age will be included up to 43) who:

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 Essure 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 Essure micro-insert 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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Essure,Hydrosalpinx, Infertility	Device: Essure Micro Insert

Collaborators and Investigators

• Sponsor: Reproductive Science Center
• Collaborators: Shady Grove Fertility

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: October 4, 2010
• First Submitted That Met QC Criteria: October 15, 2010
• First Posted (Estimate): October 18, 2010

Study Record Updates

• Last Update Posted (Estimate): October 18, 2010
• Last Update Submitted That Met QC Criteria: October 15, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Hydrosalpinx or infertility
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: IVF1