Hormonal Status, Performance and Health in Elite Female Athlete

Study Overview
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Brief Summary
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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
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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: Annual complete clinical examination : Out-of-competition follow-up, time frame 6 months medical, nutritional and respiratory monitoring biological monitoring psychological monitoring performance monitoring 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)

Official Title
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Menstrual Cycle, Amenorrhea and Contraception in Elite Female Athletes: Impact on Performance, Health and the Athlete's Biological Passport

Conditions
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Healthy

Intervention / Treatment
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* Other: Multidisciplinary monitoring of healthy women


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 groups : female athletes and leisure sports women
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Female athletes<br>highly trained subjects | Other: Multidisciplinary monitoring of healthy women<br>* Multidisciplinary monitoring<br>|
| Experimental: Leisure sport women<br>recreational sportswomen practicing regular physical activity | Other: Multidisciplinary monitoring of healthy women<br>* Multidisciplinary monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline weight | in kg, by impedancemeter | 6 months | 
| Change from baseline fat and lean mass | in kg, by impedancemeter | 6 months | 
| Change from baseline height | in cm, by height gauge | 6 months | 
| Change from baseline sex and stress hormones | concentration of oestradiol, progesterone, testosterone, DHEA, cortisol, LH and FSH in mol/L | 6 months | 
| Change from baseline food intake | food intake questionnaire to complete over 3 days, expressed in kcal/day | 6 months | 
| Change from baseline metabolic parameters | concentration of blood glucose, blood lactate, lipid profile, insulin, GH, IGF1, T3, IgA, PRL and leptin in mol/L | 6 months | 
| Change from baseline respiratory parameters | measure of FEV1 (forced expiratory volume in 1 second), expressed in % of vital capacity | 6 months | 
| Change from baseline inflammatory parameters | concentration of cytokines (TNF-alpha, IL-6) in mol/L | 6 months | 
| Change from baseline executive function | assessed by instability via static and dynamic postures (eyes open/closed) on platform | 6 months | 
| Change from baseline visual-spatial processing | 3 D mental rotation test, assessed by scores: range from 0 - 24, with 24 representing a perfect total score | 6 months | 
| Change from baseline attention and working memory | Stroop Color Word Task, assessed by scores : range of interference from -15 - +15, with higher scores representing decreased selective attention | 6 months | 
| Change from baseline performance monitoring | field performance test, performance expressed in time | 6 months | 
| Change from baseline Athlete Biological Passport (Group 2) | assessed by analysis of the standardized parameters of the Athlete Biological Passport (WADA) | 6 months | 
| Change from baseline affects (Group 2) | Positive Affect and Negative Affect Schedule (PANAS), assessed by scores. Positive Affect Score: range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score: range from 10 - 50, with lower scores representing lower levels of negative affect. | 6 months | 
| Change from baseline anxiety (Group 2) | Spielberger State-Trait Anxiety Inventory, assessed by scores: range from 20 - 80, with higher scores representing higher anxiety | 6 months | 
| Change from baseline Athlete Biological Passport (Group 1) | assessed by analysis of the standardized parameters of the Athlete Biological Passport (WADA) | 8 months | 
| Change from baseline affects (Group 1) | Positive Affect and Negative Affect Schedule (PANAS), assessed by scores. Positive Affect Score: range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score: range from 10 - 50, with lower scores representing lower levels of negative affect. | 8 months | 
| Change from baseline anxiety (Group 1) | Spielberger State-Trait Anxiety Inventory, assessed by scores: range from 20 - 80, with higher scores representing higher anxiety | 8 months | 
| Interview (Group 1) | Self-confrontation interview for questioning the action | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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female elite athlete, menstrual phase, amenorrhea, hormonal contraception, performance, health, Athlete Biological Passport