Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-24 @ 3:14 PM
NCT ID:
NCT04071392
Eligibility Criteria:
Inclusion Criteria:
1. Literate in English
2. Ages 18-50 years
3. No history of infertility, and current regular menstrual cycles occurring every 24-37 days
4. At least one full-term vaginal delivery
5. Not be at risk for pregnancy
6. Be willing to undergo a one month washout period if using the pill, patch or ring, or a three month wash out period if using Depo-Medroxyprogesterone acetate (DMPA)
7. Willing to undergo intrauterine saline infusion followed by a single HSG procedure
8. Able to understand and sign approved study informed consent form
9. Willing to complete a pre-procedure questionnaire
Exclusion Criteria:
1. Currently pregnant as confirmed by positive high-sensitivity urine pregnancy test
2. Currently using an intrauterine device (IUD) or contraceptive implant
3. Hypersensitive to radio-opaque contrast
4. History of cesarean section
5. History of tubal ligation by a method other than Essure® or Adiana
6. History recognized as clinically significant by the investigator, such as symptoms of untreated or recent pelvic infection
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04071392
Study Brief:
Protocol Section:
NCT04071392