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Completed

NCT Number: NCT05576740

Influence of Menstrual Cycle Stages on Female Athletes

The influence of the menstrual cycle on women's sports performance is still uncertain. Research on this topic shows methodological biases. The aim of the study will be to determine whether the menstrual cycle affects women's physical fitness, measuring this in 3 differentiated stages of the cycle: the early follicular phase, late follicular phase, and luteal phase. For this purpose, a blood test will be carried out in each phase, with hormone determination (oestradiol and progesterone) and a haemogram to determine the existence of possible anemia. After the extraction and other complementary tests (measurement of vital signs, bioimpedance...) the woman will undergo 3 physical tests to compare the results in the 3 phases. A group of women taking hormonal contraception will also be included, performing the same interventions. To determine whether the woman is ovulating or not, urinary luteinizing hormone (LH) strips will be given to the women and they will have to take them from day 8 of the cycle. In addition, women will wear an accelerometer to monitor their daily activity and to be able to observe if there is an influence on this stage of the menstrual cycle.

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Key information

Conditions

Menstrual Cycle Sports

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Jaume I University

Castellon, 12006, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

natural cycles group:

  • Female sex
  • Women between 18 and 40 years of age
  • Women who are members of a federation and who compete in a sport doing at least 240 minutes of exercise per week.
  • Women with regular menstrual cycles (between 23 and 38 days long).
  • Women who have not taken hormonal contraceptives (HA) for 6 months or more.

Inclusion criteria

artificial cycles group:

  • Female sex
  • Women between 18-40 years of age
  • Women federated and competed in a sport doing at least 240 minutes of exercise per week.
  • Long-term users of HA (minimum 6 months).

Exclusion criteria

Exclusion criteria

group natural cycles:

  • Refusal to participate in the study
  • Sedentary women
  • Women on HA currently or in the 6 months before the study
  • Women with irregular menstrual cycles, less than 23 or more than 38 days in length
  • Any existing metabolic disease or disorder
  • Regular use of medications or dietary supplements that could affect the results
  • Pregnancy or breastfeeding

Exclusion criteria

artificial cycles group:

  • Refusal to participate in the study
  • Sedentary women
  • Any existing metabolic disease or disorder
  • Regular use of medications or dietary supplements that could affect the results
  • Inability to manage contraception in a disciplined manner

Treatment and study plan

Determination of hormone level concentrations

Procedure

Determination of concentration of 17β-oestradiol (pg/mL), progesterone (ng/mL), LH (mUI/mL), FSH (mUI/mL), prolactin (ng/mL), total testosterone (ng/mL), free testosterone (pmol/L) sex hormone binding globulin (SHBG) (nmol/L), cortisol (μg/dL), T3 (ng/dL), T4 (mcg/dL), TSH (mcU/mL), basal insulin (mcUI/mL) during the early follicular phase, late follicular phase, and mid-luteal phase.

Jump height determination

Procedure

by Chronojump contact mat, determine five types of jump in centimeters: Squat jump without additional weight, Squat jump with 50% of body weight, Countermovement jump, Abalakov jump, and Drop jump, during the early follicular phase, late follicular phase, and mid-luteal phase.

Grip strength determination

Procedure

measuring of changes in muscle strength by handgrip dynamometer in the hand to be tested (handgrip test) during the early follicular phase, late follicular phase, and mid-luteal phase. Three attempts on each hand.

Flexibility determination

Procedure

measurement of changes in the range of motion of the hamstring musculature, by sit and reach test (cm), during the early follicular phase, late follicular phase, and mid-luteal phase. Three tries.

Indirect maximum oxygen consumption determination

Procedure

by the Course Navette test, the indirect oxygen consumption is calculated using the formula: VO2max = (6xFA) - 27,4 (FA = Speed of the last stage of the test completed. It takes place during the early follicular phase, late follicular phase, and mid-luteal phase.

Sensory and pain threshold determination

Device

by electrical muscle stimulator (Digitimer DS7A), during the early follicular phase, late follicular phase, and mid-luteal phase.

Physical and mental symptoms associated with the menstrual cycle

Other

By The Daily Record of Severity of Problems (DRSP) questionnaire, during a full menstrual cycle.

Daily activity

Device

by accelerometer (GENEActiv) during a full menstrual cylcle: Wrist-worn device measuring accelerations as a measure of daily activity, in cpm, counts per minute.

Biochemical parameters determination

Procedure

Determination of concentration of iron (μg/dL), ferritin (ng/mL), and transferrin (mg/dL), during the early follicular phase, late follicular phase, and mid-luteal phase.

Blood count determination

Procedure

Determination of concentration of hemoglobin (g/dL), red blood cells (10^6/μL), hematocrit (%), white blood cells (10^3/μl), platelets (10^3/μl), during the early follicular phase, late follicular phase, and mid-luteal phase.

Body composition parameters determination

Procedure

Determination of weight (kg), total body water (L), proteins (kg), minerals (kg), body fat mass (kg), body mass index (BMI) (kg/m2), basal metabolic rate (kcal) by Bioelectrical Impedance Analysis, during the early follicular phase, late follicular phase, and mid-luteal phase.

vital signs

Procedure

Determination of blood pressure (mmHg) and heart rate (bpm) at baseline, one minute and three minutes after the Course Navette test

Checking for correct use of contraceptive methods

Other

Pre-test questions about possible forgetfulness or mishandling of the method

Urinary LH determination

Procedure

Urine LH test strips are performed from day 8 of the cycle until positive.

Primary outcomes

  1. Change in 17β-oestradiol concentration (in pg/mL)

    Time frame: three times in a month

    concentration of 17β-oestradiol in pg/mL

  2. Change in T4 concentration (in mcg/dL)

    Time frame: three times in a month

    concentration of T4 in mcg/dL

  3. Change in T3 concentration (in ng/dL)

    Time frame: three times in a month

    concentration of T3 in ng/dL

  4. Change in cortisol concentration (in μg/dL)

    Time frame: three times in a month

    concentration of cortisol in μg/dL

  5. Change in TSH concentration (in mcUI/mL)

    Time frame: three times in a month

    concentration of thyroid-stimulating hormone (TSH) and basal insulin in mcUI/mL

  6. Change in SHBG concentration (in nmol/L)

    Time frame: three times in a month

    concentration of sex hormone binding globulin (SHBG) in nmol/L

  7. Change in free testosterone concentration (in pmol/L)

    Time frame: three times in a month

    Concentration of free testosterone in pmol/L

  8. Change in progesterone concentration (in ng/mL)

    Time frame: three times in a month

    Concentration of progesterone, prolactin and total testosterone in ng/mL

  9. Change in LH and FSH concentration (in mUI/mL)

    Time frame: three times in a month

    Concentration of luteinizing hormone (LH) and FSH (follicle stimulating hormone) in mUI/mL

  10. Change from baseline jumping height

    Time frame: three times in a month

    Measuring of change in muscle power through Squat jump without additional weight, Squat jump with 50% of body weight, Countermovement jump, Abalakov jump, and Drop jump by Chronojump contact mat, in cm. Three tries on each jump.

  11. Change from baseline grip strength

    Time frame: three times in a month

    measuring of changes in muscle strength by handgrip dynamometer in the hand to be tested (handgrip test). Three attempts on each hand.

  12. Change from baseline flexibility

    Time frame: three times in a month

    measurement of changes in the range of motion of the hamstring musculature, by sit and reach test (cm). Three tries.

  13. Change from baseline indirect maximum oxygen consumption

    Time frame: three times in a month

    by the Course Navette test

  14. Change from baseline sensory and pain threshold

    Time frame: three times in a month

    by electrical muscle stimulator (Digitimer DS7A)

  15. Change from baseline physical and mental symptoms associated with the menstrual cycle by The Daily Record of Severity of Problems questionnaire

    Time frame: Duration of a full menstrual cycle (approximately 28 days)

    By The Daily Record of Severity of Problems (DRSP) questionnaire. This scale measures symptoms subjectively from 1 to 6, where 1 corresponds to "not at all" and 6 corresponds to "extreme". The higher the score, the more severe the symptom is.

  16. Change from baseline daily activity

    Time frame: Duration of a full menstrual cycle (approximately 28 days)

    by accelerometer (GENEActiv): Wrist-worn device measuring accelerations as a measure of daily activity, in cpm, counts per minute.

Secondary outcomes

  1. Change in iron concentration (in μg/dL)

    Time frame: three times in a month

    concentration of iron in μg/dL

  2. Change in transferrin concentration (in mg/dL)

    Time frame: three times in a month

    concentration of transferrin in mg/dL

  3. Change in ferritin concentration (in ng/mL)

    Time frame: three times in a month

    concentration of ferritin in ng/mL

  4. Change in hemoglobin concentration (in g/dL)

    Time frame: three times in a month

    concentration of hemoglobin in g/dL

  5. Change in white blood cells and platelets concentration (in 10^3/μl)

    Time frame: three times in a month

    concentration of white blood cells and platelets in 10^3/μl

  6. Change in hematocrit concentration (in %)

    Time frame: three times in a month

    concentration of hematocrit in %

  7. Change in red blood cells concentration (in 10^6/μl)

    Time frame: three times in a month

    concentration of red blood cells in 10^6/μL

  8. Change in weight, proteins, minerals and body fat mass in kg

    Time frame: three times in a month

    Weight, proteins, minerals and body fat mass in kg by Bioelectrical Impedance Analysis

  9. Change in Body Mass Index (BMI) in kg/m2

    Time frame: three times in a month

    Body Mass Index (BMI) in kg/m2 by Bioelectrical Impedance Analysis and measuring tape

  10. Change in Basal metabolic rate in kcal

    Time frame: three times in a month

    Basal metabolic rate in kcal by Bioelectrical Impedance Analysis

  11. Change in total body water in liters (L)

    Time frame: three times in a month

    total body water in liters (L) by Bioelectrical Impedance Analysis

  12. Change in Blood pressure in mmHg

    Time frame: three times in a month

    Blood pressure (systolic and diastolic pressure) in mmHg at baseline, one minute and three minutes after the Course Navette test by blood pressure monitor

  13. Change in heart rate in bpm

    Time frame: three times in a month

    Heart rate in bpm at baseline, one minute and three minutes after the Course Navette test by blood pressure monitor

Sponsors and collaborators

Lead sponsor

Universitat Jaume I

Other

Registry information

Official study title

Influence of Menstrual Cycle Stages on Physical Fitness in Female Athletes

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 12, 2022
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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