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:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
NCT ID:
NCT04189406
Eligibility Criteria:
Inclusion Criteria:
In order to be eligible to participate in the TS group of this study, a subject must meet all of the following criteria:
* A diagnosis of TS before the age of three months;
* Girls with a diagnosis of classic TS or other variants (i.e. 45,X, 45,X/46XiXq, 45,X/46,XY, 45,X/46,XX, 45,X/47,XXX, 45,X/46,X,r(X), 46,XiXq, other);
* Whose parents have agreed to participate in the study through a signed written informed consent form.
In order to be eligible to participate in the control group of this study, a subject must meet all of the following criteria:
* No diagnosis of TS or any other diagnosis that might affect the HPG axis;
* Girls that will have a blood collection within their usual care at 3 months and at 9 months of age.
* Whose parents have agreed to participate in the study through a signed informed consent form.
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
* Any other diagnosis besides TS that might affect the HPG axis;
* Ovarian surgery in the medical history;
* Critical illness;
* The use of medication affecting the HPG axis (e.g. estrogen suppletion therapy)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
1 Month
Maximum Age:
3 Months
Study:
NCT04189406
Study Brief:
Protocol Section:
NCT04189406