Influence of Menstrual Cycle Stages on Female Athletes

Study Overview
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Brief Summary
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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.

Official Title
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Influence of Menstrual Cycle Stages on Physical Fitness in Female Athletes

Conditions
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Menstrual Cycle, Sports

Intervention / Treatment
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* Procedure: Determination of hormone level concentrations
* Procedure: Jump height determination
* Procedure: Grip strength determination
* Procedure: Flexibility determination
* Procedure: Indirect maximum oxygen consumption determination
* Device: Sensory and pain threshold determination
* Other: Physical and mental symptoms associated with the menstrual cycle
* Device: Daily activity
* Procedure: Biochemical parameters determination
* Procedure: Blood count determination
* Procedure: Body composition parameters determination
* Procedure: Vital signs
* Other: Checking for correct use of contraceptive methods
* Procedure: Urinary LH determination


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| natural cycle<br>In this group, women have a natural menstrual cycle, not intervened by exogenous hormones. The interventions performed in this group are the same as in the other groups. | Procedure: Determination of hormone level concentrations<br>* 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.<br>Procedure: Jump height determination<br>* 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.<br>Procedure: Grip strength determination<br>* 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.<br>Procedure: Flexibility determination<br>* 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.<br>Procedure: Indirect maximum oxygen consumption determination<br>* 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.<br>Device: Sensory and pain threshold determination<br>* by electrical muscle stimulator (Digitimer DS7A), during the early follicular phase, late follicular phase, and mid-luteal phase.<br>Other: Physical and mental symptoms associated with the menstrual cycle<br>* By The Daily Record of Severity of Problems (DRSP) questionnaire, during a full menstrual cycle.<br>Device: Daily activity<br>* by accelerometer (GENEActiv) during a full menstrual cylcle: Wrist-worn device measuring accelerations as a measure of daily activity, in cpm, counts per minute.<br>Procedure: Biochemical parameters determination<br>* 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.<br>Procedure: Blood count determination<br>* 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.<br>Procedure: Body composition parameters determination<br>* 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.<br>Procedure: Vital signs<br>* Determination of blood pressure (mmHg) and heart rate (bpm) at baseline, one minute and three minutes after the Course Navette test<br>Procedure: Urinary LH determination<br>* Urine LH test strips are performed from day 8 of the cycle until positive.<br>|
| artificial cycle<br>In this group, women with an artificial menstrual cycle, i.e. women using hormonal contraception, oral or vaginal, are selected. The interventions carried out in this group are the same as in the other groups. | Procedure: Determination of hormone level concentrations<br>* 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.<br>Procedure: Jump height determination<br>* 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.<br>Procedure: Grip strength determination<br>* 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.<br>Procedure: Flexibility determination<br>* 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.<br>Procedure: Indirect maximum oxygen consumption determination<br>* 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.<br>Device: Sensory and pain threshold determination<br>* by electrical muscle stimulator (Digitimer DS7A), during the early follicular phase, late follicular phase, and mid-luteal phase.<br>Other: Physical and mental symptoms associated with the menstrual cycle<br>* By The Daily Record of Severity of Problems (DRSP) questionnaire, during a full menstrual cycle.<br>Device: Daily activity<br>* by accelerometer (GENEActiv) during a full menstrual cylcle: Wrist-worn device measuring accelerations as a measure of daily activity, in cpm, counts per minute.<br>Procedure: Biochemical parameters determination<br>* 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.<br>Procedure: Blood count determination<br>* 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.<br>Procedure: Body composition parameters determination<br>* 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.<br>Procedure: Vital signs<br>* Determination of blood pressure (mmHg) and heart rate (bpm) at baseline, one minute and three minutes after the Course Navette test<br>Other: Checking for correct use of contraceptive methods<br>* Pre-test questions about possible forgetfulness or mishandling of the method<br>|
| natural cycle with deficient luteal phase<br>In this group, women have a natural menstrual cycle, with a low progesterone level during the luteal phase, and are not intervened by exogenous hormones. The interventions performed in this group are the same as in the other groups. | Procedure: Determination of hormone level concentrations<br>* 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.<br>Procedure: Jump height determination<br>* 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.<br>Procedure: Grip strength determination<br>* 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.<br>Procedure: Flexibility determination<br>* 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.<br>Procedure: Indirect maximum oxygen consumption determination<br>* 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.<br>Device: Sensory and pain threshold determination<br>* by electrical muscle stimulator (Digitimer DS7A), during the early follicular phase, late follicular phase, and mid-luteal phase.<br>Other: Physical and mental symptoms associated with the menstrual cycle<br>* By The Daily Record of Severity of Problems (DRSP) questionnaire, during a full menstrual cycle.<br>Device: Daily activity<br>* by accelerometer (GENEActiv) during a full menstrual cylcle: Wrist-worn device measuring accelerations as a measure of daily activity, in cpm, counts per minute.<br>Procedure: Biochemical parameters determination<br>* 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.<br>Procedure: Blood count determination<br>* 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.<br>Procedure: Body composition parameters determination<br>* 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.<br>Procedure: Vital signs<br>* Determination of blood pressure (mmHg) and heart rate (bpm) at baseline, one minute and three minutes after the Course Navette test<br>Procedure: Urinary LH determination<br>* Urine LH test strips are performed from day 8 of the cycle until positive.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 17β-oestradiol concentration (in pg/mL) | concentration of 17β-oestradiol in pg/mL | three times in a month | 
| Change in T4 concentration (in mcg/dL) | concentration of T4 in mcg/dL | three times in a month | 
| Change in T3 concentration (in ng/dL) | concentration of T3 in ng/dL | three times in a month | 
| Change in cortisol concentration (in μg/dL) | concentration of cortisol in μg/dL | three times in a month | 
| Change in TSH concentration (in mcUI/mL) | concentration of thyroid-stimulating hormone (TSH) and basal insulin in mcUI/mL | three times in a month | 
| Change in SHBG concentration (in nmol/L) | concentration of sex hormone binding globulin (SHBG) in nmol/L | three times in a month | 
| Change in free testosterone concentration (in pmol/L) | Concentration of free testosterone in pmol/L | three times in a month | 
| Change in progesterone concentration (in ng/mL) | Concentration of progesterone, prolactin and total testosterone in ng/mL | three times in a month | 
| Change in LH and FSH concentration (in mUI/mL) | Concentration of luteinizing hormone (LH) and FSH (follicle stimulating hormone) in mUI/mL | three times in a month | 
| Change from baseline jumping height | 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. | three times in a month | 
| Change from baseline grip strength | measuring of changes in muscle strength by handgrip dynamometer in the hand to be tested (handgrip test). Three attempts on each hand. | three times in a month | 
| Change from baseline flexibility | measurement of changes in the range of motion of the hamstring musculature, by sit and reach test (cm). Three tries. | three times in a month | 
| Change from baseline indirect maximum oxygen consumption | by the Course Navette test | three times in a month | 
| Change from baseline sensory and pain threshold | by electrical muscle stimulator (Digitimer DS7A) | three times in a month | 
| Change from baseline physical and mental symptoms associated with the menstrual cycle by The Daily Record of Severity of Problems questionnaire | 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. | Duration of a full menstrual cycle (approximately 28 days) | 
| Change from baseline daily activity | by accelerometer (GENEActiv): Wrist-worn device measuring accelerations as a measure of daily activity, in cpm, counts per minute. | Duration of a full menstrual cycle (approximately 28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in iron concentration (in μg/dL) | concentration of iron in μg/dL | three times in a month | 
| Change in transferrin concentration (in mg/dL) | concentration of transferrin in mg/dL | three times in a month | 
| Change in ferritin concentration (in ng/mL) | concentration of ferritin in ng/mL | three times in a month | 
| Change in hemoglobin concentration (in g/dL) | concentration of hemoglobin in g/dL | three times in a month | 
| Change in white blood cells and platelets concentration (in 10^3/μl) | concentration of white blood cells and platelets in 10^3/μl | three times in a month | 
| Change in hematocrit concentration (in %) | concentration of hematocrit in % | three times in a month | 
| Change in red blood cells concentration (in 10^6/μl) | concentration of red blood cells in 10^6/μL | three times in a month | 
| Change in weight, proteins, minerals and body fat mass in kg | Weight, proteins, minerals and body fat mass in kg by Bioelectrical Impedance Analysis | three times in a month | 
| Change in Body Mass Index (BMI) in kg/m2 | Body Mass Index (BMI) in kg/m2 by Bioelectrical Impedance Analysis and measuring tape | three times in a month | 
| Change in Basal metabolic rate in kcal | Basal metabolic rate in kcal by Bioelectrical Impedance Analysis | three times in a month | 
| Change in total body water in liters (L) | total body water in liters (L) by Bioelectrical Impedance Analysis | three times in a month | 
| Change in Blood pressure in mmHg | Blood pressure (systolic and diastolic pressure) in mmHg at baseline, one minute and three minutes after the Course Navette test by blood pressure monitor | three times in a month | 
| Change in heart rate in bpm | Heart rate in bpm at baseline, one minute and three minutes after the Course Navette test by blood pressure monitor | three times in a month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menstrual cycle, Performance, Hormonal verification, Contraception