Influence of Menstrual Cycle Stages on Female Athletes

Menstrual Cycle Clinical Trial

Official title:

Influence of Menstrual Cycle Stages on Physical Fitness in Female Athletes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05576740
• Other study ID #: CD/77/2020
• Status: Completed
• Start date: March 16, 2022
• Est. completion date: July 15, 2022

Study information

• Verified date: December 2022
• Source: Universitat Jaume I
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Menstrual Cycle
• Sports

Intervention

Procedure:
• Determination of hormone level concentrations
Determination of concentration of 17ß-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
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
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
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
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.
• 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.
• 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.
• 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

Procedure:
• Urinary LH determination
Urine LH test strips are performed from day 8 of the cycle until positive.

Locations

Country	Name	City	State
Spain	Jaume I University	Castelló de la Plana	Castellon

Sponsors (1)

Lead Sponsor	Collaborator
Universitat Jaume I

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 17ß-oestradiol concentration (in pg/mL)	concentration of 17ß-oestradiol in pg/mL	three times in a month
Primary	Change in T4 concentration (in mcg/dL)	concentration of T4 in mcg/dL	three times in a month
Primary	Change in T3 concentration (in ng/dL)	concentration of T3 in ng/dL	three times in a month
Primary	Change in cortisol concentration (in µg/dL)	concentration of cortisol in µg/dL	three times in a month
Primary	Change in TSH concentration (in mcUI/mL)	concentration of thyroid-stimulating hormone (TSH) and basal insulin in mcUI/mL	three times in a month
Primary	Change in SHBG concentration (in nmol/L)	concentration of sex hormone binding globulin (SHBG) in nmol/L	three times in a month
Primary	Change in free testosterone concentration (in pmol/L)	Concentration of free testosterone in pmol/L	three times in a month
Primary	Change in progesterone concentration (in ng/mL)	Concentration of progesterone, prolactin and total testosterone in ng/mL	three times in a month
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change from baseline indirect maximum oxygen consumption	by the Course Navette test	three times in a month
Primary	Change from baseline sensory and pain threshold	by electrical muscle stimulator (Digitimer DS7A)	three times in a month
Primary	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)
Primary	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	Change in iron concentration (in µg/dL)	concentration of iron in µg/dL	three times in a month
Secondary	Change in transferrin concentration (in mg/dL)	concentration of transferrin in mg/dL	three times in a month
Secondary	Change in ferritin concentration (in ng/mL)	concentration of ferritin in ng/mL	three times in a month
Secondary	Change in hemoglobin concentration (in g/dL)	concentration of hemoglobin in g/dL	three times in a month
Secondary	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
Secondary	Change in hematocrit concentration (in %)	concentration of hematocrit in %	three times in a month
Secondary	Change in red blood cells concentration (in 10^6/µl)	concentration of red blood cells in 10^6/µL	three times in a month
Secondary	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
Secondary	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
Secondary	Change in Basal metabolic rate in kcal	Basal metabolic rate in kcal by Bioelectrical Impedance Analysis	three times in a month
Secondary	Change in total body water in liters (L)	total body water in liters (L) by Bioelectrical Impedance Analysis	three times in a month
Secondary	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
Secondary	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