Influence of Menstrual Cycle Stages on Female Athletes

Completed

• Conditions: Menstrual Cycle; Sports
• Interventions: 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

• Registration Number: NCT05576740
• Lead Sponsor: Universitat Jaume I

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-16
• Primary Completion: 2022-07-15
• Study Completion: 2022-07-15
• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-10-09
• Study First Posted: 2022-10-12
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-18
• Last Update Posted: 2022-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
artificial cycle	Sensory and pain threshold determination	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.
natural cycle	Jump height determination	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.
natural cycle	Flexibility determination	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.
natural cycle	Biochemical parameters determination	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.
natural cycle	Blood count determination	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.
natural cycle	Vital signs	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.
artificial cycle	Blood count determination	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.
artificial cycle	Body composition parameters determination	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.
natural cycle	Urinary LH determination	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.
natural cycle	Determination of hormone level concentrations	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.
natural cycle	Grip strength determination	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.
natural cycle	Indirect maximum oxygen consumption determination	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.
natural cycle	Physical and mental symptoms associated with the menstrual 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.
natural cycle	Sensory and pain threshold determination	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.
natural cycle	Daily activity	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.
artificial cycle	Determination of hormone level concentrations	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.
natural cycle with deficient luteal phase	Determination of hormone level concentrations	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.
natural cycle with deficient luteal phase	Flexibility determination	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.
natural cycle	Body composition parameters determination	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.
artificial cycle	Jump height determination	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.
artificial cycle	Grip strength determination	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.
artificial cycle	Physical and mental symptoms associated with the menstrual 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.
artificial cycle	Checking for correct use of contraceptive methods	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.
natural cycle with deficient luteal phase	Sensory and pain threshold determination	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.
natural cycle with deficient luteal phase	Physical and mental symptoms associated with the menstrual cycle	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.
natural cycle with deficient luteal phase	Daily activity	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.
natural cycle with deficient luteal phase	Vital signs	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.
artificial cycle	Flexibility determination	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.
artificial cycle	Indirect maximum oxygen consumption determination	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.
artificial cycle	Daily activity	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.
natural cycle with deficient luteal phase	Grip strength determination	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.
natural cycle with deficient luteal phase	Indirect maximum oxygen consumption determination	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.
natural cycle with deficient luteal phase	Biochemical parameters determination	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.
artificial cycle	Biochemical parameters determination	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.
artificial cycle	Vital signs	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.
natural cycle with deficient luteal phase	Body composition parameters determination	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.
natural cycle with deficient luteal phase	Urinary LH determination	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.
natural cycle with deficient luteal phase	Jump height determination	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.
natural cycle with deficient luteal phase	Blood count determination	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.

Primary Outcome Measures

Name	Time	Method
Change in 17β-oestradiol concentration (in pg/mL)	three times in a month	concentration of 17β-oestradiol in pg/mL
Change from baseline grip strength	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.
Change from baseline indirect maximum oxygen consumption	three times in a month	by the Course Navette test
Change in cortisol concentration (in μg/dL)	three times in a month	concentration of cortisol in μg/dL
Change in TSH concentration (in mcUI/mL)	three times in a month	concentration of thyroid-stimulating hormone (TSH) and basal insulin in mcUI/mL
Change in SHBG concentration (in nmol/L)	three times in a month	concentration of sex hormone binding globulin (SHBG) in nmol/L
Change in progesterone concentration (in ng/mL)	three times in a month	Concentration of progesterone, prolactin and total testosterone in ng/mL
Change in T3 concentration (in ng/dL)	three times in a month	concentration of T3 in ng/dL
Change in LH and FSH concentration (in mUI/mL)	three times in a month	Concentration of luteinizing hormone (LH) and FSH (follicle stimulating hormone) in mUI/mL
Change from baseline sensory and pain threshold	three times in a month	by electrical muscle stimulator (Digitimer DS7A)
Change from baseline physical and mental symptoms associated with the menstrual cycle by The Daily Record of Severity of Problems questionnaire	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.
Change in T4 concentration (in mcg/dL)	three times in a month	concentration of T4 in mcg/dL
Change in free testosterone concentration (in pmol/L)	three times in a month	Concentration of free testosterone in pmol/L
Change from baseline jumping height	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.
Change from baseline flexibility	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.
Change from baseline daily activity	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 Outcome Measures

Name	Time	Method
Change in hemoglobin concentration (in g/dL)	three times in a month	concentration of hemoglobin in g/dL
Change in Basal metabolic rate in kcal	three times in a month	Basal metabolic rate in kcal by Bioelectrical Impedance Analysis
Change in iron concentration (in μg/dL)	three times in a month	concentration of iron in μg/dL
Change in total body water in liters (L)	three times in a month	total body water in liters (L) by Bioelectrical Impedance Analysis
Change in Blood pressure in mmHg	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
Change in transferrin concentration (in mg/dL)	three times in a month	concentration of transferrin in mg/dL
Change in ferritin concentration (in ng/mL)	three times in a month	concentration of ferritin in ng/mL
Change in white blood cells and platelets concentration (in 10^3/μl)	three times in a month	concentration of white blood cells and platelets in 10\^3/μl
Change in weight, proteins, minerals and body fat mass in kg	three times in a month	Weight, proteins, minerals and body fat mass in kg by Bioelectrical Impedance Analysis
Change in heart rate in bpm	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
Change in hematocrit concentration (in %)	three times in a month	concentration of hematocrit in %
Change in red blood cells concentration (in 10^6/μl)	three times in a month	concentration of red blood cells in 10\^6/μL
Change in Body Mass Index (BMI) in kg/m2	three times in a month	Body Mass Index (BMI) in kg/m2 by Bioelectrical Impedance Analysis and measuring tape

Trial Locations

Locations (1)

Jaume I University; 🇪🇸 Castelló de la Plana, Castellon, Spain