Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Contraception
  • Contraceptive Device; Complications
  • Sterility, Female
Type
Observational
Design
Observational Model: CohortTime Perspective: Retrospective

Participation Requirements

Age
Between 18 years and 50 years
Gender
Only males

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 ...

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.

Tracking Information

NCT #
NCT03438682
Collaborators
  • 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