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 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT02835469
Eligibility Criteria:
Inclusion Criteria:
* Decision made to prescribe Menopur® multidose according to Summary of product characteristics
* The study cycle will be either
* 1st controlled ovarian stimulation cycle ever, or
* 2nd controlled ovarian stimulation cycle ever, or
* 1st or 2nd controlled ovarian stimulation cycle after having achieved ongoing pregnancy in a previous controlled ovarian stimulation cycle (note: the subject cannot be included if she has had made more than one failed cycle before the cycle resulting in ongoing pregnancy)
Exclusion Criteria:
* Known ovarian disease (e.g. ovarian cysts, polycystic ovarian disease etc.)
* Diagnosed as "poor responder", defined as either
* \>20 days of gonadotrophin stimulation in a previous controlled ovarian stimulation cycle, or
* any previous cancellation of a controlled ovarian stimulation cycle due to limited follicular response, or
* development of less than 4 follicles ≥15 mm in a previous controlled ovarian stimulation cycle
* Ovarian hyperstimulation syndrome (OHSS)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
19 Years
Maximum Age:
40 Years
Study:
NCT02835469
Study Brief:
Protocol Section:
NCT02835469