Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT05028959
Brief Summary:
The repercussions of the hormonal status of high-level sportswomen on their performance and health as well as on the Athlete's Biological Passport (ABP) have been little studied and remain poorly known. The investigators therefore propose to contribute to the improvement of current knowledge by determining, thanks to the implementation of a multidisciplinary monitoring, with the use of various tests and matrices, in female elite athletes and recreational athletes (control group):
* 1\) the impact of cycle phase, absence of cycle or contraceptive use on physical and psychological performance, health as well as on ABP;
* 2\) the potential confounding effects of the athlete's environment
* 3\) correlations between the different matrices analyzed
Detailed Description:
Volunteers to be studied: 80 healthy female subjects (16 to 30 years old), divided into 2 groups:
Group 1: 60 athletes, from different sports disciplines, in amenorrhea, with menstrual cycle or taking contraceptives
Group 2: 20 leisure sports subjects with menstrual cycle or taking contraceptives
Following the oral and written information of the project, the subjects have a minimum of 15 days of reflection before signing the written consent form. They will have the possibility, at any time, to voluntarily interrupt the study without having to justify themselves.
Investigations to be performed:
1. Annual complete clinical examination :
2. "Out-of-competition" follow-up, time frame 6 months
* medical, nutritional and respiratory monitoring
* biological monitoring
* psychological monitoring
* performance monitoring
3. Non-invasive "in-competition" monitoring, only for Group 1, once in a year on the day before/after a major competition:
* biological monitoring
* psychological monitoring
* performance monitoring (interview)
Study:
NCT05028959
Study Brief:
Protocol Section:
NCT05028959