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

NCT ID: NCT01221974

Last Updated: 2010-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Study Groups

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Essure,Hydrosalpinx, Infertility

Group Type EXPERIMENTAL

Essure Micro Insert

Intervention Type DEVICE

Interventions

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Essure Micro Insert

Intervention Type DEVICE

Eligibility Criteria

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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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Minimum Eligible Age

21 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shady Grove Fertility

UNKNOWN

Sponsor Role collaborator

Reproductive Science Center

INDUSTRY

Sponsor Role lead

Responsible Party

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Reproducitve Science Center

Locations

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Reproductive Science Center

San Ramon, California, United States

Site Status

Countries

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United States

Other Identifiers

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IVF1

Identifier Type: -

Identifier Source: org_study_id