Influence of Menstrual Cycle Stages on Female Athletes

Influence of Menstrual Cycle Stages on Physical Fitness in 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.

Study Overview

• Status: Completed
• Conditions: Menstrual Cycle; Sports
• Intervention / Treatment: 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; Procedure: Urinary LH determination; Other: Checking for correct use of contraceptive methods

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• Spain
  • Castellon
    • Castelló de la Plana, Castellon, Spain, 12006
      • Jaume I University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women between 18 and 40 years old, with regular menstrual cycles, who practice sport regularly, proven by federation and competition in a sport, and confirming the completion of at least 240 minutes of physical activity per week. In the case of women with hormonal contraception, they must be with the established method (minimum 6 months with it).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
natural cycle; 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; 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.; Procedure: Jump height determination; 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.; Procedure: Grip strength determination; 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.; Procedure: Flexibility determination; 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.; Procedure: Indirect maximum oxygen consumption determination; 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.; Device: Sensory and pain threshold determination; by electrical muscle stimulator (Digitimer DS7A), during the early follicular phase, late follicular phase, and mid-luteal phase.; Other: Physical and mental symptoms associated with the menstrual cycle; By The Daily Record of Severity of Problems (DRSP) questionnaire, during a full menstrual cycle.; Device: Daily activity; by accelerometer (GENEActiv) during a full menstrual cylcle: Wrist-worn device measuring accelerations as a measure of daily activity, in cpm, counts per minute.; Procedure: Biochemical parameters determination; 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.; Procedure: Blood count determination; 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.; Procedure: Body composition parameters determination; 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.; Procedure: Vital signs; Determination of blood pressure (mmHg) and heart rate (bpm) at baseline, one minute and three minutes after the Course Navette test; Procedure: Urinary LH determination; Urine LH test strips are performed from day 8 of the cycle until positive.
artificial cycle; 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; 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.; Procedure: Jump height determination; 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.; Procedure: Grip strength determination; 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.; Procedure: Flexibility determination; 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.; Procedure: Indirect maximum oxygen consumption determination; 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.; Device: Sensory and pain threshold determination; by electrical muscle stimulator (Digitimer DS7A), during the early follicular phase, late follicular phase, and mid-luteal phase.; Other: Physical and mental symptoms associated with the menstrual cycle; By The Daily Record of Severity of Problems (DRSP) questionnaire, during a full menstrual cycle.; Device: Daily activity; by accelerometer (GENEActiv) during a full menstrual cylcle: Wrist-worn device measuring accelerations as a measure of daily activity, in cpm, counts per minute.; Procedure: Biochemical parameters determination; 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.; Procedure: Blood count determination; 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.; Procedure: Body composition parameters determination; 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.; Procedure: Vital signs; Determination of blood pressure (mmHg) and heart rate (bpm) at baseline, one minute and three minutes after the Course Navette test; Other: Checking for correct use of contraceptive methods; Pre-test questions about possible forgetfulness or mishandling of the method
natural cycle with deficient luteal phase; 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; 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.; Procedure: Jump height determination; 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.; Procedure: Grip strength determination; 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.; Procedure: Flexibility determination; 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.; Procedure: Indirect maximum oxygen consumption determination; 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.; Device: Sensory and pain threshold determination; by electrical muscle stimulator (Digitimer DS7A), during the early follicular phase, late follicular phase, and mid-luteal phase.; Other: Physical and mental symptoms associated with the menstrual cycle; By The Daily Record of Severity of Problems (DRSP) questionnaire, during a full menstrual cycle.; Device: Daily activity; by accelerometer (GENEActiv) during a full menstrual cylcle: Wrist-worn device measuring accelerations as a measure of daily activity, in cpm, counts per minute.; Procedure: Biochemical parameters determination; 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.; Procedure: Blood count determination; 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.; Procedure: Body composition parameters determination; 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.; Procedure: Vital signs; Determination of blood pressure (mmHg) and heart rate (bpm) at baseline, one minute and three minutes after the Course Navette test; Procedure: Urinary LH determination; Urine LH test strips are performed from day 8 of the cycle until positive.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitat Jaume I
• Investigators: Principal Investigator: Paula Recacha-Ponce, Midwife, Jaume I University; Study Director: Eladio Collado-Boira, Doctor, Jaume I University; Study Director: Carlos Hernando-Domingo, Doctor, Jaume I University

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2022
• Primary Completion (Actual): July 15, 2022
• Study Completion (Actual): July 15, 2022

Study Registration Dates

• First Submitted: October 6, 2022
• First Submitted That Met QC Criteria: October 9, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Estimate): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 18, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Contraception; Performance; Menstrual cycle; Hormonal verification
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Reproductive Control Agents; Contraceptive Agents; Hormones
• Other Study ID Numbers: CD/77/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The aim is to publish the results obtained in high impact journals.
• IPD Sharing Time Frame: results are expected to be available from 2023 when the data will be analysed and the results published.The data will always be available for consultation.
• IPD Sharing Access Criteria: open acces
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No