Clinical trial NCT05028959: Hormonal Status, Performance and Health in Elite Female Athlete
Official title: Menstrual Cycle, Amenorrhea and Contraception in Elite Female Athletes: Impact on Performance, Health and the Athlete's Biological Passport
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: female elite athlete
menstrual phase
amenorrhea
hormonal contraception
performance
health
Athlete Biological Passport
Lead sponsor: Université Paris-Saclay-Assistance publique des hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 80
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups : female athletes and leisure sports women
Primary purpose: OTHER

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)

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline weight
timeFrame: 6 months
measure: Change from baseline fat and lean mass
timeFrame: 6 months
measure: Change from baseline height
timeFrame: 6 months
measure: Change from baseline sex and stress hormones
timeFrame: 6 months
measure: Change from baseline food intake
timeFrame: 6 months
measure: Change from baseline metabolic parameters
timeFrame: 6 months
measure: Change from baseline respiratory parameters
timeFrame: 6 months
measure: Change from baseline inflammatory parameters
timeFrame: 6 months
measure: Change from baseline executive function
timeFrame: 6 months
measure: Change from baseline visual-spatial processing
timeFrame: 6 months
measure: Change from baseline attention and working memory
timeFrame: 6 months
measure: Change from baseline performance monitoring
timeFrame: 6 months
measure: Change from baseline Athlete Biological Passport (Group 2)
timeFrame: 6 months
measure: Change from baseline affects (Group 2)
timeFrame: 6 months
measure: Change from baseline anxiety (Group 2)
timeFrame: 6 months
measure: Change from baseline Athlete Biological Passport (Group 1)
timeFrame: 8 months
measure: Change from baseline affects (Group 1)
timeFrame: 8 months
measure: Change from baseline anxiety (Group 1)
timeFrame: 8 months
measure: Interview (Group 1)
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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