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

Women Who Suffer From Hydrosalpinx That is Causing Infertility and Whom Want a Safer Way of Treamtent Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01221974
• Other study ID #: IVF1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 4, 2010
• Last updated: October 15, 2010
• Start date: July 2008

Study information

• Verified date: October 2010
• Source: Reproductive Science Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 38 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Women Who Suffer From Hydrosalpinx That is Causing Infertility and Whom Want a Safer Way of Treamtent

Intervention

Device:
• Essure Micro Insert

Locations

Country	Name	City	State
United States	Reproductive Science Center	San Ramon	California

Sponsors (2)

Lead Sponsor	Collaborator
Reproductive Science Center	Shady Grove Fertility

Country where clinical trial is conducted

United States,