- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03438682
Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Aims:
Aim 1. To compare the real world effectiveness of hysteroscopic sterilization, laparoscopic sterilization and intrauterine devices (IUDs) by calculating:
- Pregnancy rates at 3, 6, 12, 24, 36, 48, and 60 months post-procedure, indicating sterilization failure.
- 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:
- 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.
- 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).
- Identify sociodemographic and pre-sterilization clinical variables which may predict complications following hysteroscopic sterilization compared to laparoscopic sterilization and to IUDs.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06510
- Yale University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Essure Hysteroscopic Sterilization
Women who have undergone Essure hysteroscopic sterilization
|
Essure hysteroscopic sterilization
|
Laparoscopic Sterilization
Women who have undergone laparoscopic sterilization
|
Laparoscopic sterilization via electrocautery, ring, or clip.
|
Intrauterine device (IUD) placement
Women who have undergone IUD placement
|
Intrauterine Device (IUD)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Pregnancy rates at 3 months post-procedure
|
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
|
Pregnancy rates at 6 months post-procedure
|
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
|
Pregnancy rates at 12 months post-procedure
|
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
|
Pregnancy rates at 24 months post-procedure
|
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
|
Pregnancy rates at 36 months post-procedure
|
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
|
Pregnancy rates at 48 months post-procedure
|
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
|
Pregnancy rates at 60 months post-procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 months post-procedure
|
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
|
6 months post-procedure
|
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
|
12 months post-procedure
|
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
|
24 months post-procedure
|
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
|
36 months post-procedure
|
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
|
48 months post-procedure
|
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
|
60 months post-procedure
|
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
|
3 months post-procedure
|
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
|
6 months post-procedure
|
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
|
12 months post-procedure
|
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
|
24 months post-procedure
|
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
|
36 months post-procedure
|
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
|
48 months post-procedure
|
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
|
60 months post-procedure
|
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
|
3 months post-procedure
|
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
|
6 months post-procedure
|
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
|
12 months post-procedure
|
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
|
24 months post-procedure
|
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
|
36 months post-procedure
|
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
|
48 months post-procedure
|
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
|
60 months post-procedure
|
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
|
3 months post-procedure
|
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
|
6 months post-procedure
|
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
|
12 months post-procedure
|
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
|
24 months post-procedure
|
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
|
36 months post-procedure
|
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
|
48 months post-procedure
|
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
|
60 months post-procedure
|
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
|
3 months post-procedure
|
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
|
6 months post-procedure
|
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
|
12 months post-procedure
|
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
|
24 months post-procedure
|
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
|
36 months post-procedure
|
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
|
48 months post-procedure
|
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
|
60 months post-procedure
|
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
|
Up to 1-year pre-procedure
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Aileen Gariepy, MD, Yale University
Publications and helpful links
General Publications
- 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 Feb 23:1-8. doi: 10.1007/s11606-022-07433-4. Online ahead of print.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000020734
- 1U01FD005938-01 (U.S. FDA Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Contraception
-
Virginia Commonwealth UniversityCompletedPregnancy Related | Contraception | Contraception Behavior | Contraception Use
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedFemale Contraception | Contraception
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Medical University of South CarolinaSociety of Family PlanningCompletedContraception | Contraception BehaviorUnited States
-
Teva Branded Pharmaceutical Products R&D, Inc.CompletedFemale Contraception | ContraceptionUnited States, Israel
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedFemale Contraception | Contraception
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedFemale Contraception | Contraception
-
Janssen Pharmaceutica N.V., BelgiumCompleted
-
University of California, San FranciscoAgency for Healthcare Research and Quality (AHRQ); Essential Access HealthNot yet recruitingContraception | Contraception Behavior | Reproductive BehaviorUnited States
Clinical Trials on Essure
-
Centre Hospitalier Universitaire de NīmesTerminated
-
Reproductive Science CenterShady Grove FertilityCompletedWomen Who Suffer From Hydrosalpinx That is Causing Infertility and Whom Want a Safer Way of TreamtentUnited States
-
BayerCompletedContraception | MenorrhagiaUnited States
-
BayerActive, not recruiting
-
Hospices Civils de LyonCompletedQuality of Life | Contraceptive Device; ComplicationsFrance
-
BayerHôpital André Mignot Centre Hospitalier de VersaillesCompleted
-
University of New MexicoBayer; Society of Family PlanningCompletedContraception | Inhalation of Nitrous OxideUnited States