Influence of Menstrual Cycle Stages on Female Athletes
1 other identifier
observational
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2022
CompletedFirst Submitted
Initial submission to the registry
October 6, 2022
CompletedFirst Posted
Study publicly available on registry
October 12, 2022
CompletedDecember 21, 2022
December 1, 2022
4 months
October 6, 2022
December 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (16)
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 Outcomes (13)
Change in iron concentration (in μg/dL)
three times in a month
Change in transferrin concentration (in mg/dL)
three times in a month
Change in ferritin concentration (in ng/mL)
three times in a month
Change in hemoglobin concentration (in g/dL)
three times in a month
Change in white blood cells and platelets concentration (in 10^3/μl)
three times in a month
- +8 more secondary outcomes
Study Arms (3)
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.
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.
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.
Interventions
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.
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.
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.
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.
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.
by electrical muscle stimulator (Digitimer DS7A), during the early follicular phase, late follicular phase, and mid-luteal phase.
By The Daily Record of Severity of Problems (DRSP) questionnaire, during a full menstrual cycle.
by accelerometer (GENEActiv) during a full menstrual cylcle: Wrist-worn device measuring accelerations as a measure of daily activity, in cpm, counts per minute.
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.
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.
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.
Determination of blood pressure (mmHg) and heart rate (bpm) at baseline, one minute and three minutes after the Course Navette test
Pre-test questions about possible forgetfulness or mishandling of the method
Urine LH test strips are performed from day 8 of the cycle until positive.
Eligibility Criteria
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).
You may qualify if:
- 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.
- 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).
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jaume I University
Castellon, Castellon, 12006, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paula Recacha-Ponce, Midwife
Universitat Jaume I
- STUDY DIRECTOR
Eladio Collado-Boira, Doctor
Universitat Jaume I
- STUDY DIRECTOR
Carlos Hernando-Domingo, Doctor
Universitat Jaume I
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigador principal
Study Record Dates
First Submitted
October 6, 2022
First Posted
October 12, 2022
Study Start
March 16, 2022
Primary Completion
July 15, 2022
Study Completion
July 15, 2022
Last Updated
December 21, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- 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.
- Access Criteria
- open acces
The aim is to publish the results obtained in high impact journals.