Influence of Menstrual Cycle Stages on Female Athletes

December 18, 2022 updated by: Paula Recacha Ponce, Universitat Jaume I

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in 17β-oestradiol concentration (in pg/mL)
Time Frame: three times in a month
concentration of 17β-oestradiol in pg/mL
three times in a month
Change in T4 concentration (in mcg/dL)
Time Frame: three times in a month
concentration of T4 in mcg/dL
three times in a month
Change in T3 concentration (in ng/dL)
Time Frame: three times in a month
concentration of T3 in ng/dL
three times in a month
Change in cortisol concentration (in μg/dL)
Time Frame: three times in a month
concentration of cortisol in μg/dL
three times in a month
Change in TSH concentration (in mcUI/mL)
Time Frame: three times in a month
concentration of thyroid-stimulating hormone (TSH) and basal insulin in mcUI/mL
three times in a month
Change in SHBG concentration (in nmol/L)
Time Frame: three times in a month
concentration of sex hormone binding globulin (SHBG) in nmol/L
three times in a month
Change in free testosterone concentration (in pmol/L)
Time Frame: three times in a month
Concentration of free testosterone in pmol/L
three times in a month
Change in progesterone concentration (in ng/mL)
Time Frame: three times in a month
Concentration of progesterone, prolactin and total testosterone in ng/mL
three times in a month
Change in LH and FSH concentration (in mUI/mL)
Time Frame: three times in a month
Concentration of luteinizing hormone (LH) and FSH (follicle stimulating hormone) in mUI/mL
three times in a month
Change from baseline jumping height
Time Frame: 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.
three times in a month
Change from baseline grip strength
Time Frame: 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.
three times in a month
Change from baseline flexibility
Time Frame: 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.
three times in a month
Change from baseline indirect maximum oxygen consumption
Time Frame: three times in a month
by the Course Navette test
three times in a month
Change from baseline sensory and pain threshold
Time Frame: three times in a month
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
Time Frame: 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.
Duration of a full menstrual cycle (approximately 28 days)
Change from baseline daily activity
Time Frame: 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.
Duration of a full menstrual cycle (approximately 28 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in iron concentration (in μg/dL)
Time Frame: three times in a month
concentration of iron in μg/dL
three times in a month
Change in transferrin concentration (in mg/dL)
Time Frame: three times in a month
concentration of transferrin in mg/dL
three times in a month
Change in ferritin concentration (in ng/mL)
Time Frame: three times in a month
concentration of ferritin in ng/mL
three times in a month
Change in hemoglobin concentration (in g/dL)
Time Frame: three times in a month
concentration of hemoglobin in g/dL
three times in a month
Change in white blood cells and platelets concentration (in 10^3/μl)
Time Frame: three times in a month
concentration of white blood cells and platelets in 10^3/μl
three times in a month
Change in hematocrit concentration (in %)
Time Frame: three times in a month
concentration of hematocrit in %
three times in a month
Change in red blood cells concentration (in 10^6/μl)
Time Frame: three times in a month
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
Time Frame: three times in a month
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
Time Frame: three times in a month
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
Time Frame: three times in a month
Basal metabolic rate in kcal by Bioelectrical Impedance Analysis
three times in a month
Change in total body water in liters (L)
Time Frame: three times in a month
total body water in liters (L) by Bioelectrical Impedance Analysis
three times in a month
Change in Blood pressure in mmHg
Time Frame: 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
three times in a month
Change in heart rate in bpm
Time Frame: 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
three times in a month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitat Jaume I

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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