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

This study has been completed.
Sponsor:
Collaborator:
Shady Grove Fertility
Information provided by:
Reproductive Science Center
ClinicalTrials.gov Identifier:
NCT01221974
First received: October 4, 2010
Last updated: October 15, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Women Who Suffer From Hydrosalpinx That is Causing Infertility and Whom Want a Safer Way of Treamtent
Device: Essure Micro Insert
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Reproductive Science Center:

Study Start Date: July 2008
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Essure,Hydrosalpinx, Infertility Device: Essure Micro Insert

  Eligibility

Ages Eligible for Study:   21 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221974

Locations
United States, California
Reproductive Science Center
San Ramon, California, United States, 94583
Sponsors and Collaborators
Reproductive Science Center
Shady Grove Fertility
  More Information

No publications provided

Responsible Party: Donald Galen M.D., Reproducitve Science Center
ClinicalTrials.gov Identifier: NCT01221974     History of Changes
Other Study ID Numbers: IVF1
Study First Received: October 4, 2010
Last Updated: October 15, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Reproductive Science Center:
Hydrosalpinx or infertility

Additional relevant MeSH terms:
Infertility
Salpingitis
Genital Diseases, Male
Genital Diseases, Female
Fallopian Tube Diseases
Adnexal Diseases
Pelvic Inflammatory Disease

ClinicalTrials.gov processed this record on September 18, 2014