Hormonal Status, Performance and Health in Elite Female Athlete (FEMMES)

Université Paris-Saclay-Assistance publique des hôpitaux de Paris

Status: Not yet enrolling

Conditions: Healthy

Treatments: Other: Multidisciplinary monitoring of healthy women

Study type: Interventional

Funder types: Other

Identifiers

NCT05028959

FEM-2020

Details and patient eligibility

About

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

Full 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)

Enrollment: 80 estimated patients

Sex: Female

Ages: 16 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Group 1: high-level athletes (qualified for national/international championships and/or training at least 15 hours/week)
• Group 2: recreational athletes who practice a regular physical activity

Exclusion criteria

• Participation in another trial
• History of cardiac pathology
• High blood pressure
• History of ulcers and other gastrointestinal disorders
• Myasthenia
• Renal insufficiency
• Person not affiliated or not benefiting from a social security system

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Female athletes

Experimental group

Description:

highly trained subjects

Treatment:

Other: Multidisciplinary monitoring of healthy women

Leisure sport women

Experimental group

Description:

recreational sportswomen practicing regular physical activity

Treatment:

Other: Multidisciplinary monitoring of healthy women