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:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT06806358
Eligibility Criteria:
Inclusion Criteria:
* Age 20 -41 years
* BMI 18-25 kg/m2
* Women with any parity seeking contraception and choosing IUD as their preferred method after proper and thorough counseling
* Regularly menstruating women (duration of menstruation 3-7 days and length of cycle 22- 35 days).
* Not using any hormonal therapy or anticoagulation
Exclusion Criteria:
* Cervical abnormalities.
* Pregnancy or suspicion of pregnancy
* Congenital or acquired uterine anomalies which distort the uterine cavity (fibroids, endometrial polyps, cervical stenosis, bicornuate uterus, hypoplastic uterus \< 6 cm)
* Acute PID or a history of PID within the past 3 months
* Postpartum or post-abortion endometritis within the past 3 months
* Current STI or within the past 3 months (including cervicitis)
* Cervical cancer
* Endometrial cancer
* Malignant gestational trophoblastic disease
* Undiagnosed vaginal bleeding
* Hypersensitivity to any component in the IUD (copper)
* Less than 6 weeks postpartum.
* Neurological or psychological conditions that may affect pain sensation
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
41 Years
Study:
NCT06806358
Study Brief:
Protocol Section:
NCT06806358