NCT03438682

Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization

Completed Last updated 3 November 2021

What this trial tests

trial testing Essure in Sterility, Female in 89,203 participants. Completed in 31 July 2021.

Timeline

30 September 2018

Primary endpoint
31 July 2021

31 July 2021

Quick facts

Lead sponsor	Yale University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	89,203
Start date	30 September 2018
Primary completion	31 July 2021
Estimated completion	31 July 2021
Sites	1 location across United States

Drugs / interventions tested

• Essure
• Laparoscopic sterilization
• Intrauterine Device (IUD)

Conditions studied

• Sterility, Female — all drugs for Sterility, Female →
• Contraception — all drugs for Contraception →
• Contraceptive Device; Complications — all drugs for Contraceptive Device; Complications →

Sponsor

Yale University

Who can join

Adults 18 to 50, female only, with Sterility, Female or Contraception. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

More than 345,000 U.S. women undergo either tubal ligation ("getting her tubes tied") or Essure procedures each year to permanently avoid pregnancy. Both prevent pregnancy by blocking women's Fallopian tubes but neither are 100% effective. Both can have complications, but not enough is known to help women make an informed choice between the two.

Essure is popular because it can be performed without anesthesia in a doctor's office and women can return to work the next day. However, patients have reported that the Essure procedure was unexpectedly painful. Also, women need to use other contraceptives for 3 months and then return for testing, to make sure their tubes are blocked and will prevent pregnancy. Not all women return for this test and some may get pregnant before realizing their Essure didn't work.

Essure was approved by the Food and Drug Administration (FDA) in 2002, but no studies ever compared it to tubal ligation. By 2015, over 9,000 women reported serious complications to the FDA. Women who were unhappy with Essure found each other online and created a Facebook "Essure Problems" support group that now has over 31,000 members. After an FDA Advisory Board expressed concerns about Essure's risks, in 2016 the FDA required stronger warnings about complications and announced that "more rigorous research" was needed, demanding Essure's maker conduct a new study comparing the benefits and risks of Essure to tubal ligation. Unfortunately, that study will not be finished before September 2023.

To provide answers as rapidly as possible for women considering sterilization, we will analyze data from the medical records of thousands of women with sterilization procedures funded by California's Medicaid. As poor women and women of color have different experiences with healthcare, and they more often choose sterilization, comparing these women's experiences with Essure and tubal ligation is very important. We will compare the safety and effectiveness of the 2 sterilization procedures to answer:

* How many women got pregnant afterwards?
* How many operations did each woman need to become infertile?
* Which complications did women have (i.e. chronic pain, depression)? We will also check whether certain women (such as certain age groups or those with diabetes) were most likely to have problems after either procedure.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Comparative Effectiveness and Safety of Intrauterine Contraception and Tubal Ligation.
   Schwarz EB, Lewis CA, Dove MS, Murphy E, et al · · 2022 · cited 14× · PMID 35194746 · DOI 10.1007/s11606-022-07433-4
2. Comparative effectiveness of hysteroscopic and laparoscopic sterilization for women: a retrospective cohort study.
   Gariepy AM, Lewis C, Zuckerman D, Tancredi DJ, et al · · 2022 · cited 3× · PMID 35428480 · DOI 10.1016/j.fertnstert.2022.03.001
3. Patient-Centered Safety Outcomes After Hysteroscopic Compared With Laparoscopic Sterilization.
   Gariepy AM, Lewis C, Zuckerman D, Tancredi DJ, et al · · 2022 · PMID 35115444 · DOI 10.1097/aog.0000000000004690