Hormonal Status, Performance and Health in Elite Female Athlete

NCT05028959 | Unknown

• 1 other identifier: FEM-2020
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy

Keywords

female elite athlete; menstrual phase; amenorrhea; hormonal contraception; performance; health; Athlete Biological Passport

Outcome Measures

Primary Outcomes (19)

• 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

Study Arms (2)

Female athletes

EXPERIMENTAL

highly trained subjects

Other: Multidisciplinary monitoring of healthy women

Leisure sport women

EXPERIMENTAL

recreational sportswomen practicing regular physical activity

Other: Multidisciplinary monitoring of healthy women

Interventions

Multidisciplinary monitoring of healthy women OTHER

Multidisciplinary monitoring

Female athletes; Leisure sport women

Eligibility Criteria

• Age: 16 Years - 30 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université Paris-Saclay-Assistance publique des hôpitaux de Paris: lead

Related Publications (15)

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  PMID: 30301734 BACKGROUND

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  PMID: 29953884 BACKGROUND

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  PMID: 26872589 BACKGROUND

• Cornelli U, Belcaro G, Cesarone MR, Finco A. Analysis of oxidative stress during the menstrual cycle. Reprod Biol Endocrinol. 2013 Aug 2;11:74. doi: 10.1186/1477-7827-11-74.

  PMID: 23915183 BACKGROUND

• Eklund E, Berglund B, Labrie F, Carlstrom K, Ekstrom L, Hirschberg AL. Serum androgen profile and physical performance in women Olympic athletes. Br J Sports Med. 2017 Sep;51(17):1301-1308. doi: 10.1136/bjsports-2017-097582. Epub 2017 Jun 23.

  PMID: 28646101 BACKGROUND

• Emami F, Kordi Yoosefinejad A, Motealleh A. Comparison of static and dynamic balance during early follicular and ovulation phases in healthy women, using simple, clinical tests: a cross sectional study. Gynecol Endocrinol. 2019 Mar;35(3):257-260. doi: 10.1080/09513590.2018.1519788. Epub 2018 Oct 23.

  PMID: 30350735 BACKGROUND

• Hausmann M, Slabbekoorn D, Van Goozen SH, Cohen-Kettenis PT, Gunturkun O. Sex hormones affect spatial abilities during the menstrual cycle. Behav Neurosci. 2000 Dec;114(6):1245-50. doi: 10.1037//0735-7044.114.6.1245.

  PMID: 11142657 BACKGROUND

• Julian R, Hecksteden A, Fullagar HH, Meyer T. The effects of menstrual cycle phase on physical performance in female soccer players. PLoS One. 2017 Mar 13;12(3):e0173951. doi: 10.1371/journal.pone.0173951. eCollection 2017.

  PMID: 28288203 BACKGROUND

• Kishali NF, Imamoglu O, Katkat D, Atan T, Akyol P. Effects of menstrual cycle on sports performance. Int J Neurosci. 2006 Dec;116(12):1549-63. doi: 10.1080/00207450600675217.

  PMID: 17145688 BACKGROUND

• Kluft C, Leuven JA, Helmerhorst FM, Krans HM. Pro-inflammatory effects of oestrogens during use of oral contraceptives and hormone replacement treatment. Vascul Pharmacol. 2002 Aug;39(3):149-54. doi: 10.1016/s1537-1891(02)00304-x.

  PMID: 12616983 BACKGROUND

• Langdeau JB, Day A, Turcotte H, Boulet LP. Gender differences in the prevalence of airway hyperresponsiveness and asthma in athletes. Respir Med. 2009 Mar;103(3):401-6. doi: 10.1016/j.rmed.2008.09.023. Epub 2008 Nov 21.

  PMID: 19027280 BACKGROUND

• Lebrun CM, Petit MA, McKenzie DC, Taunton JE, Prior JC. Decreased maximal aerobic capacity with use of a triphasic oral contraceptive in highly active women: a randomised controlled trial. Br J Sports Med. 2003 Aug;37(4):315-20. doi: 10.1136/bjsm.37.4.315.

  PMID: 12893716 BACKGROUND

• Nose-Ogura S, Yoshino O, Dohi M, Kigawa M, Harada M, Hiraike O, Onda T, Osuga Y, Fujii T, Saito S. Risk factors of stress fractures due to the female athlete triad: Differences in teens and twenties. Scand J Med Sci Sports. 2019 Oct;29(10):1501-1510. doi: 10.1111/sms.13464. Epub 2019 Jun 9.

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• Otaka M, Chen SM, Zhu Y, Tsai YS, Tseng CY, Fogt DL, Lim BH, Huang CY, Kuo CH. Does ovulation affect performance in tennis players? BMJ Open Sport Exerc Med. 2018 Jan 27;4(1):e000305. doi: 10.1136/bmjsem-2017-000305. eCollection 2018.

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• Schaumberg MA, Jenkins DG, Janse DE Jonge XA, Emmerton LM, Skinner TL. Oral Contraceptive Use Dampens Physiological Adaptations to Sprint Interval Training. Med Sci Sports Exerc. 2017 Apr;49(4):717-727. doi: 10.1249/MSS.0000000000001171.

  PMID: 27898641 BACKGROUND

MeSH Terms

Conditions

Amenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Emmanuelle DURON, PU-PH

CONTACT

33144083503; emmanuelle.duron@aphp.fr

Christine Le-Scanff, PU

CONTACT

33169156198; christine.le-scanff@universite-paris-saclay.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Geriatry, Principal investigator

Model Details: 2 groups : female athletes and leisure sports women

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: August 31, 2021
• Study Start: September 15, 2021
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2025
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share