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

• ClinicalTrials.gov Identifier: NCT03438682
• Recruitment Status: Completed
• First Posted: February 20, 2018
• Last Update Posted: November 3, 2021
• Sponsor: Yale University
• Collaborators: University of California, Davis; National Center for Health Research; Patient-Centered Outcomes Research Institute; Food and Drug Administration (FDA)
• Information provided by (Responsible Party): Yale University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Sterility, Female; Contraception; Contraceptive Device; Complications	Device: Essure; Procedure: Laparoscopic sterilization; Device: Intrauterine Device (IUD)

Detailed Description:

Study Aims:

Aim 1. To compare the real world effectiveness of hysteroscopic sterilization, laparoscopic sterilization and intrauterine devices (IUDs) by calculating:

1. Pregnancy rates at 3, 6, 12, 24, 36, 48, and 60 months post-procedure, indicating sterilization failure.
2. Patient's ability to rely on sterilization after hysteroscopic sterilization (blocked tubes on hysterosalpingogram) compared to laparoscopic sterilization and IUDs at 3, 6, 12, 24, 36, 48, and 60 months post-procedure, indicating concern of sterilization failure.

Aim 2. To compare safety and complications after hysteroscopic sterilization laparoscopic sterilization, and IUD placement by:

1. Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement at 3, 6, 12, 24, 36, 48, and 60 months post-procedure.
2. Evaluating other outcomes suggested by patient partners, including additional surgeries due to complications, chronic pain, and/or depression, by measuring claims for narcotic prescriptions, and antidepressants at 3, 6, 12, 24, 36, 48, 60 months post-procedure (hysteroscopic sterilization, laparoscopic sterilization, or IUD placement).
3. Identify sociodemographic and pre-sterilization clinical variables which may predict complications following hysteroscopic sterilization compared to laparoscopic sterilization and to IUDs.

Study Design

• Study Type: Observational
• Actual Enrollment: 89203 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
• Actual Study Start Date: September 30, 2018
• Actual Primary Completion Date: July 31, 2021
• Actual Study Completion Date: July 31, 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
Essure Hysteroscopic Sterilization; Women who have undergone Essure hysteroscopic sterilization	Device: Essure; Essure hysteroscopic sterilization
Laparoscopic Sterilization; Women who have undergone laparoscopic sterilization	Procedure: Laparoscopic sterilization; Laparoscopic sterilization via electrocautery, ring, or clip.
Intrauterine device (IUD) placement; Women who have undergone IUD placement	Device: Intrauterine Device (IUD); Intrauterine Device (IUD)

Outcome Measures

Primary Outcome Measures :

1. Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) [ Time Frame: Pregnancy rates at 3 months post-procedure ]
   Pregnancy after sterilization or IUD placement, indicating failure
2. Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) [ Time Frame: Pregnancy rates at 6 months post-procedure ]
   Pregnancy after sterilization or IUD placement, indicating failure
3. Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) [ Time Frame: Pregnancy rates at 12 months post-procedure ]
   Pregnancy after sterilization or IUD placement, indicating failure
4. Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) [ Time Frame: Pregnancy rates at 24 months post-procedure ]
   Pregnancy after sterilization or IUD placement, indicating failure
5. Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) [ Time Frame: Pregnancy rates at 36 months post-procedure ]
   Pregnancy after sterilization or IUD placement, indicating failure
6. Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) [ Time Frame: Pregnancy rates at 48 months post-procedure ]
   Pregnancy after sterilization or IUD placement, indicating failure
7. Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) [ Time Frame: Pregnancy rates at 60 months post-procedure ]
   Pregnancy after sterilization or IUD placement, indicating failure

Secondary Outcome Measures :

1. Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) [ Time Frame: 3 months post-procedure ]
   Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs
2. Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) [ Time Frame: 6 months post-procedure ]
   Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs
3. Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) [ Time Frame: 12 months post-procedure ]
   Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs
4. Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) [ Time Frame: 24 months post-procedure ]
   Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs
5. Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) [ Time Frame: 36 months post-procedure ]
   Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs
6. Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) [ Time Frame: 48 months post-procedure ]
   Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs
7. Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) [ Time Frame: 60 months post-procedure ]
   Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs
8. Reoperation to achieve sterilization or reinsertion to achieve IUD placement [ Time Frame: 3 months post-procedure ]
   Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement
9. Reoperation to achieve sterilization or reinsertion to achieve IUD placement [ Time Frame: 6 months post-procedure ]
   Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement
10. Reoperation to achieve sterilization or reinsertion to achieve IUD placement [ Time Frame: 12 months post-procedure ]
    Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement
11. Reoperation to achieve sterilization or reinsertion to achieve IUD placement [ Time Frame: 24 months post-procedure ]
    Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement
12. Reoperation to achieve sterilization or reinsertion to achieve IUD placement [ Time Frame: 36 months post-procedure ]
    Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement
13. Reoperation to achieve sterilization or reinsertion to achieve IUD placement [ Time Frame: 48 months post-procedure ]
    Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement
14. Reoperation to achieve sterilization or reinsertion to achieve IUD placement [ Time Frame: 60 months post-procedure ]
    Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement
15. Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) [ Time Frame: 3 months post-procedure ]
    Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
16. Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) [ Time Frame: 6 months post-procedure ]
    Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
17. Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) [ Time Frame: 12 months post-procedure ]
    Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
18. Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) [ Time Frame: 24 months post-procedure ]
    Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
19. Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) [ Time Frame: 36 months post-procedure ]
    Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
20. Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) [ Time Frame: 48 months post-procedure ]
    Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
21. Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) [ Time Frame: 60 months post-procedure ]
    Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
22. Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics [ Time Frame: 3 months post-procedure ]
    New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement
23. Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics [ Time Frame: 6 months post-procedure ]
    New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement
24. Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics [ Time Frame: 12 months post-procedure ]
    New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement
25. Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics [ Time Frame: 24 months post-procedure ]
    New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement
26. Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics [ Time Frame: 36 months post-procedure ]
    New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement
27. Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics [ Time Frame: 48 months post-procedure ]
    New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement
28. Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics [ Time Frame: 60 months post-procedure ]
    New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement
29. Number of participants with new onset depression as assessed by new prescriptions for antidepressants [ Time Frame: 3 months post-procedure ]
    New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement
30. Number of participants with new onset depression as assessed by new prescriptions for antidepressants [ Time Frame: 6 months post-procedure ]
    New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement
31. Number of participants with new onset depression as assessed by new prescriptions for antidepressants [ Time Frame: 12 months post-procedure ]
    New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement
32. Number of participants with new onset depression as assessed by new prescriptions for antidepressants [ Time Frame: 24 months post-procedure ]
    New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement
33. Number of participants with new onset depression as assessed by new prescriptions for antidepressants [ Time Frame: 36 months post-procedure ]
    New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement
34. Number of participants with new onset depression as assessed by new prescriptions for antidepressants [ Time Frame: 48 months post-procedure ]
    New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement
35. Number of participants with new onset depression as assessed by new prescriptions for antidepressants [ Time Frame: 60 months post-procedure ]
    New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement
36. Pre-procedure clinical variables associated with procedural complications [ Time Frame: Up to 1-year pre-procedure ]
    Identify sociodemographic and pre-procedure clinical variables which may predict complications following hysteroscopic sterilization compared to laparoscopic sterilization and IUD placement

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

We will use linked data from Centers for Medicare and Medicaid Services (CMS) Research Data Assistance Center (ResDAC) including research identifiable files (RIF) containing Medicaid records, known as the Medicaid Analytic Extract (MAX) files to identify women who have undergone hysteroscopic or laparoscopic sterilization procedures or IUD placement. The MAX files contain claims, encounters, and eligibility information on recipients of California's Medicaid program (Medi-Cal).

Criteria

Inclusion Criteria:

• Women aged 18-50 years at the time of sterilization procedure
• Claims indicating hysteroscopic or laparoscopic sterilization procedures or IUD placement

Exclusion Criteria:

• Active cancer
• Any conditions that would have excluded the patient for hysteroscopic sterilization
• Any conditions that would have excluded the patient for laparoscopic sterilization

Contacts and Locations

Locations

United States, Connecticut

Yale University School of Medicine

New Haven, Connecticut, United States, 06510

Sponsors and Collaborators

Yale University

University of California, Davis

National Center for Health Research

Patient-Centered Outcomes Research Institute

Food and Drug Administration (FDA)

Investigators

• Principal Investigator: Aileen Gariepy, MD; Yale University

More Information

Additional Information:

This work was (partially) supported through a Patient-Centered Outcomes Research Institute (PCORI) Award 1609-36359 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gariepy AM, Lewis C, Zuckerman D, Tancredi DJ, Murphy E, McDonald-Mosley R, Sonalkar S, Hathaway M, Nunez-Eddy C, Schwarz EB. Comparative effectiveness of hysteroscopic and laparoscopic sterilization for women: a retrospective cohort study. Fertil Steril. 2022 Jun;117(6):1322-1331. doi: 10.1016/j.fertnstert.2022.03.001. Epub 2022 Apr 12.

Schwarz EB, Lewis CA, Dove MS, Murphy E, Zuckerman D, Nunez-Eddy C, Tancredi DJ, McDonald-Mosley R, Sonalkar S, Hathaway M, Gariepy AM. Comparative Effectiveness and Safety of Intrauterine Contraception and Tubal Ligation. J Gen Intern Med. 2022 Dec;37(16):4168-4175. doi: 10.1007/s11606-022-07433-4. Epub 2022 Feb 23.

Gariepy AM, Lewis C, Zuckerman D, Tancredi DJ, Murphy E, McDonald-Mosley R, Sonalkar S, Hathaway M, Nunez-Eddy C, Schwarz EB. Patient-Centered Safety Outcomes After Hysteroscopic Compared With Laparoscopic Sterilization. Obstet Gynecol. 2022 Mar 1;139(3):423-432. doi: 10.1097/AOG.0000000000004690.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT03438682
• Other Study ID Numbers: 2000020734; 1U01FD005938-01 ( U.S. FDA Grant/Contract )
• First Posted: February 20, 2018
• Last Update Posted: November 3, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Infertility; Infertility, Female