Sterility, FemaleNCT03438682
Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
An observational study of Sterility, Female and Contraception, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sterility, Female, Contraception, Contraceptive Device; Complications
- What is being tested?
- Essure, Laparoscopic sterilization and Intrauterine Device (IUD)
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 89,203 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2018to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- Women aged 18-50 years at the time of sterilization procedure
- Claims indicating hysteroscopic or laparoscopic sterilization procedures or IUD placement
Who cannot join
- Active cancer
- Any conditions that would have excluded the patient for hysteroscopic sterilization
- Any conditions that would have excluded the patient for laparoscopic sterilization
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06510
About this study
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.
Read more
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.
Read the 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.
- Being tested
- Essure, Laparoscopic sterilization, Intrauterine Device (IUD)
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EssureDevice
Essure hysteroscopic sterilization
Laparoscopic sterilizationProcedure or surgery
Laparoscopic sterilization via electrocautery, ring, or clip.
Intrauterine Device (IUD)Device
Intrauterine Device (IUD)
| Study group | Role | What they receive |
|---|---|---|
| Essure Hysteroscopic Sterilization | Women who have undergone Essure hysteroscopic sterilization Receives: Device: Essure | |
| Laparoscopic Sterilization | Women who have undergone laparoscopic sterilization Receives: Procedure: Laparoscopic sterilization | |
| Intrauterine device (IUD) placement | Women who have undergone IUD placement Receives: Device: Intrauterine Device (IUD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a)
Pregnancy after sterilization or IUD placement, indicating failure
Measured: Pregnancy rates at 3 months post-procedure
Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a)
Pregnancy after sterilization or IUD placement, indicating failure
Measured: Pregnancy rates at 6 months post-procedure
Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a)
Pregnancy after sterilization or IUD placement, indicating failure
Measured: Pregnancy rates at 12 months post-procedure
Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a)
Pregnancy after sterilization or IUD placement, indicating failure
Measured: Pregnancy rates at 24 months post-procedure
Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a)
Pregnancy after sterilization or IUD placement, indicating failure
Measured: Pregnancy rates at 36 months post-procedure
Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a)
Pregnancy after sterilization or IUD placement, indicating failure
Measured: Pregnancy rates at 48 months post-procedure
Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a)
Pregnancy after sterilization or IUD placement, indicating failure
Measured: Pregnancy rates at 60 months post-procedure
Secondary outcomes (36)
Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b)
Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs
Measured: 3 months post-procedure
Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b)
Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs
Measured: 6 months post-procedure
Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b)
Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs
Measured: 12 months post-procedure
Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b)
Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs
Measured: 24 months post-procedure
Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b)
Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs
Measured: 36 months post-procedure
Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b)
Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs
Measured: 48 months post-procedure
Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b)
Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs
Measured: 60 months post-procedure
Reoperation to achieve sterilization or reinsertion to achieve IUD placement
Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement
Measured: 3 months post-procedure
Reoperation to achieve sterilization or reinsertion to achieve IUD placement
Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement
Measured: 6 months post-procedure
Reoperation to achieve sterilization or reinsertion to achieve IUD placement
Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement
Measured: 12 months post-procedure
Reoperation to achieve sterilization or reinsertion to achieve IUD placement
Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement
Measured: 24 months post-procedure
Reoperation to achieve sterilization or reinsertion to achieve IUD placement
Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement
Measured: 36 months post-procedure
Reoperation to achieve sterilization or reinsertion to achieve IUD placement
Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement
Measured: 48 months post-procedure
Reoperation to achieve sterilization or reinsertion to achieve IUD placement
Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement
Measured: 60 months post-procedure
Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy)
Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
Measured: 3 months post-procedure
Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy)
Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
Measured: 6 months post-procedure
Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy)
Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
Measured: 12 months post-procedure
Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy)
Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
Measured: 24 months post-procedure
Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy)
Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
Measured: 36 months post-procedure
Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy)
Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
Measured: 48 months post-procedure
Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy)
Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy
Measured: 60 months post-procedure
Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics
New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement
Measured: 3 months post-procedure
Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics
New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement
Measured: 6 months post-procedure
Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics
New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement
Measured: 12 months post-procedure
Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics
New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement
Measured: 24 months post-procedure
Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics
New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement
Measured: 36 months post-procedure
Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics
New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement
Measured: 48 months post-procedure
Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics
New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement
Measured: 60 months post-procedure
Number of participants with new onset depression as assessed by new prescriptions for antidepressants
New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement
Measured: 3 months post-procedure
Number of participants with new onset depression as assessed by new prescriptions for antidepressants
New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement
Measured: 6 months post-procedure
Number of participants with new onset depression as assessed by new prescriptions for antidepressants
New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement
Measured: 12 months post-procedure
Number of participants with new onset depression as assessed by new prescriptions for antidepressants
New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement
Measured: 24 months post-procedure
Number of participants with new onset depression as assessed by new prescriptions for antidepressants
New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement
Measured: 36 months post-procedure
Number of participants with new onset depression as assessed by new prescriptions for antidepressants
New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement
Measured: 48 months post-procedure
Number of participants with new onset depression as assessed by new prescriptions for antidepressants
New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement
Measured: 60 months post-procedure
Pre-procedure clinical variables associated with procedural complications
Identify sociodemographic and pre-procedure clinical variables which may predict complications following hysteroscopic sterilization compared to laparoscopic sterilization and IUD placement
Measured: Up to 1-year pre-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start30 Sep 2018
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sterility, FemaleStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 89,203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis, National Center for Health Research, Patient-Centered Outcomes Research Institute, Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Aileen Gariepy, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438682
- Sponsor's protocol ID
- 2000020734
- Other IDs
- 1U01FD005938-01
- Status last verified
- Nov 2021
- First submitted
- 29 Jan 2018
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 35428480Schwarz 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.
PubMed 35194746Gariepy 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.
PubMed 35115444
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
- ClinicalTrials.gov ID
- NCT03438682
- Acronym / sponsor ID
- 2000020734
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89,203 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- University of California, Davis, National Center for Health Research, Patient-Centered Outcomes Research Institute, Food and Drug Administration (FDA)
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 20 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Essure Hysteroscopic Sterilization | – | Device: EssureWomen who have undergone Essure hysteroscopic sterilization |
| Laparoscopic Sterilization | – | Procedure: Laparoscopic sterilizationWomen who have undergone laparoscopic sterilization |
| Intrauterine device (IUD) placement | – | Device: Intrauterine Device (IUD)Women who have undergone IUD placement |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (2 listed)
- Women aged 18-50 years at the time of sterilization procedure
- Claims indicating hysteroscopic or laparoscopic sterilization procedures or IUD placement
Key exclusion criteria (3 listed)
- Active cancer
- Any conditions that would have excluded the patient for hysteroscopic sterilization
- Any conditions that would have excluded the patient for laparoscopic sterilization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EssureEssure hysteroscopic sterilization | Device | Essure Hysteroscopic Sterilization |
| Laparoscopic sterilizationLaparoscopic sterilization via electrocautery, ring, or clip. | Procedure or surgery | Laparoscopic Sterilization |
| Intrauterine Device (IUD)Intrauterine Device (IUD) | Device | Intrauterine device (IUD) placement |
Primary outcome
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
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
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
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
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
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
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
36 secondary outcomes
Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b)
Time frame: 3 months post-procedure
Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b)
Time frame: 6 months post-procedure
Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b)
Time frame: 12 months post-procedure
Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b)
Time frame: 24 months post-procedure
Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b)
Time frame: 36 months post-procedure
Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b)
Time frame: 48 months post-procedure
Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b)
Time frame: 60 months post-procedure
Reoperation to achieve sterilization or reinsertion to achieve IUD placement
Time frame: 3 months post-procedure
Reoperation to achieve sterilization or reinsertion to achieve IUD placement
Time frame: 6 months post-procedure
Reoperation to achieve sterilization or reinsertion to achieve IUD placement
Time frame: 12 months post-procedure
Reoperation to achieve sterilization or reinsertion to achieve IUD placement
Time frame: 24 months post-procedure
Reoperation to achieve sterilization or reinsertion to achieve IUD placement
Time frame: 36 months post-procedure
Reoperation to achieve sterilization or reinsertion to achieve IUD placement
Time frame: 48 months post-procedure
Reoperation to achieve sterilization or reinsertion to achieve IUD placement
Time frame: 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 subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy)
Time frame: 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 subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy)
Time frame: 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 subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy)
Time frame: 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
Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics
Time frame: 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
Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics
Time frame: 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
Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics
Time frame: 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
Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics
Time frame: 60 months post-procedure
Number of participants with new onset depression as assessed by new prescriptions for antidepressants
Time frame: 3 months post-procedure
Number of participants with new onset depression as assessed by new prescriptions for antidepressants
Time frame: 6 months post-procedure
Number of participants with new onset depression as assessed by new prescriptions for antidepressants
Time frame: 12 months post-procedure
Number of participants with new onset depression as assessed by new prescriptions for antidepressants
Time frame: 24 months post-procedure
Number of participants with new onset depression as assessed by new prescriptions for antidepressants
Time frame: 36 months post-procedure
Number of participants with new onset depression as assessed by new prescriptions for antidepressants
Time frame: 48 months post-procedure
Number of participants with new onset depression as assessed by new prescriptions for antidepressants
Time frame: 60 months post-procedure
Pre-procedure clinical variables associated with procedural complications
Time frame: Up to 1-year pre-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Derived from this study: PubMed 35428480Gariepy 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.
- Derived from this study: PubMed 35194746Schwarz 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.
- Derived from this study: PubMed 35115444Gariepy 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.
- This work was (partially) supported through a Patient-Centered Outcomes Research Institute (PCORI) Award 1609-36359Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aileen Gariepy, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sterility, Female and Contraception, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) (time frame: Pregnancy rates at 3 months post-procedure). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03438682, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.