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

August 30, 2021 updated by: Emmanuelle Duron, Université Paris-Saclay-Assistance publique des hôpitaux de Paris

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline weight
Time Frame: 6 months
in kg, by impedancemeter
6 months
Change from baseline fat and lean mass
Time Frame: 6 months
in kg, by impedancemeter
6 months
Change from baseline height
Time Frame: 6 months
in cm, by height gauge
6 months
Change from baseline sex and stress hormones
Time Frame: 6 months
concentration of oestradiol, progesterone, testosterone, DHEA, cortisol, LH and FSH in mol/L
6 months
Change from baseline food intake
Time Frame: 6 months
food intake questionnaire to complete over 3 days, expressed in kcal/day
6 months
Change from baseline metabolic parameters
Time Frame: 6 months
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
Time Frame: 6 months
measure of FEV1 (forced expiratory volume in 1 second), expressed in % of vital capacity
6 months
Change from baseline inflammatory parameters
Time Frame: 6 months
concentration of cytokines (TNF-alpha, IL-6) in mol/L
6 months
Change from baseline executive function
Time Frame: 6 months
assessed by instability via static and dynamic postures (eyes open/closed) on platform
6 months
Change from baseline visual-spatial processing
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
field performance test, performance expressed in time
6 months
Change from baseline Athlete Biological Passport (Group 2)
Time Frame: 6 months
assessed by analysis of the standardized parameters of the Athlete Biological Passport (WADA)
6 months
Change from baseline affects (Group 2)
Time Frame: 6 months
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)
Time Frame: 6 months
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)
Time Frame: 8 months
assessed by analysis of the standardized parameters of the Athlete Biological Passport (WADA)
8 months
Change from baseline affects (Group 1)
Time Frame: 8 months
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)
Time Frame: 8 months
Spielberger State-Trait Anxiety Inventory, assessed by scores: range from 20 - 80, with higher scores representing higher anxiety
8 months
Interview (Group 1)
Time Frame: 8 months
Self-confrontation interview for questioning the action
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université Paris-Saclay-Assistance publique des hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 15, 2021

Primary Completion (Anticipated)

May 31, 2023

Study Completion (Anticipated)

May 31, 2025

Study Registration Dates

First Submitted

June 21, 2021

First Submitted That Met QC Criteria

August 30, 2021

First Posted (Actual)

August 31, 2021

Study Record Updates

Last Update Posted (Actual)

August 31, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FEM-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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