Menstrual CycleNCT05576740
Influence of Menstrual Cycle Stages on Female Athletes
An observational study of Menstrual Cycle and Sports, run by Universitat Jaume I at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cycle, Sports
- What is being tested?
- Determination of hormone level concentrations, Jump height determination and Grip strength determination
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- How many people
- 41 participants
- Where
- 1 siteSpain
- Study dates
- 16 Mar 2022to 15 Jul 2022
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- 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
Show all 9Show fewer
- 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).
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Menstrual Cycle, Sports
- Being tested
- Determination of hormone level concentrations, Jump height determination, Grip strength determination, Flexibility determination, Indirect maximum oxygen consumption determination
- Keywords
- Menstrual cycle, Performance, Hormonal verification, Contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of hormone level concentrationsProcedure or surgery
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.
Jump height determinationProcedure or surgery
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 determinationProcedure or surgery
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 determinationProcedure or surgery
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 determinationProcedure or surgery
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.
Sensory and pain threshold determinationDevice
by electrical muscle stimulator (Digitimer DS7A), during the early follicular phase, late follicular phase, and mid-luteal phase.
Physical and mental symptoms associated with the menstrual cycleOther
By The Daily Record of Severity of Problems (DRSP) questionnaire, during a full menstrual cycle.
Daily activityDevice
by accelerometer (GENEActiv) during a full menstrual cylcle: Wrist-worn device measuring accelerations as a measure of daily activity, in cpm, counts per minute.
Biochemical parameters determinationProcedure or surgery
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 determinationProcedure or surgery
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 determinationProcedure or surgery
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 signsProcedure or surgery
Determination of blood pressure (mmHg) and heart rate (bpm) at baseline, one minute and three minutes after the Course Navette test
Checking for correct use of contraceptive methodsOther
Pre-test questions about possible forgetfulness or mishandling of the method
Urinary LH determinationProcedure or surgery
Urine LH test strips are performed from day 8 of the cycle until positive.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 | |
| 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. Receives: 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; Other: Checking for correct use of contraceptive methods | |
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 17β-oestradiol concentration (in pg/mL)
concentration of 17β-oestradiol in pg/mL
Measured: three times in a month
Change in T4 concentration (in mcg/dL)
concentration of T4 in mcg/dL
Measured: three times in a month
Change in T3 concentration (in ng/dL)
concentration of T3 in ng/dL
Measured: three times in a month
Change in cortisol concentration (in μg/dL)
concentration of cortisol in μg/dL
Measured: three times in a month
Change in TSH concentration (in mcUI/mL)
concentration of thyroid-stimulating hormone (TSH) and basal insulin in mcUI/mL
Measured: three times in a month
Change in SHBG concentration (in nmol/L)
concentration of sex hormone binding globulin (SHBG) in nmol/L
Measured: three times in a month
Change in free testosterone concentration (in pmol/L)
Concentration of free testosterone in pmol/L
Measured: three times in a month
Change in progesterone concentration (in ng/mL)
Concentration of progesterone, prolactin and total testosterone in ng/mL
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: three times in a month
Change from baseline indirect maximum oxygen consumption
by the Course Navette test
Measured: three times in a month
Change from baseline sensory and pain threshold
by electrical muscle stimulator (Digitimer DS7A)
Measured: 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.
Measured: 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.
Measured: Duration of a full menstrual cycle (approximately 28 days)
Secondary outcomes (13)
Change in iron concentration (in μg/dL)
concentration of iron in μg/dL
Measured: three times in a month
Change in transferrin concentration (in mg/dL)
concentration of transferrin in mg/dL
Measured: three times in a month
Change in ferritin concentration (in ng/mL)
concentration of ferritin in ng/mL
Measured: three times in a month
Change in hemoglobin concentration (in g/dL)
concentration of hemoglobin in g/dL
Measured: 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
Measured: three times in a month
Change in hematocrit concentration (in %)
concentration of hematocrit in %
Measured: three times in a month
Change in red blood cells concentration (in 10^6/μl)
concentration of red blood cells in 10^6/μL
Measured: 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
Measured: 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
Measured: three times in a month
Change in Basal metabolic rate in kcal
Basal metabolic rate in kcal by Bioelectrical Impedance Analysis
Measured: three times in a month
Change in total body water in liters (L)
total body water in liters (L) by Bioelectrical Impedance Analysis
Measured: 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
Measured: 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
Measured: three times in a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start16 Mar 2022
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menstrual CycleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Recacha Ponce, Universitat Jaume I
- Investigators
- Paula Recacha-Ponce, Midwife, Principal investigator, Universitat Jaume IEladio Collado-Boira, Doctor, Study director, Universitat Jaume ICarlos Hernando-Domingo, Doctor, Study director, Universitat Jaume I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576740
- Sponsor's protocol ID
- CD/77/2020
- Status last verified
- Dec 2022
- First submitted
- 6 Oct 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The aim is to publish the results obtained in high impact journals.
Publications
Recacha-Ponce P, Suarez-Alcazar P, Hernando C, Salas-Medina P, Muriach M, Balino P, Guisado-Cuadrado I, Collado-Boira E. Hormonal balance, anovulatory cycles and luteal phase deficiency: exploring relationships between hematological variables, sex hormones and V̇O2max in athletes. Reprod Fertil. 2025 Apr 28;6(2):e240119. doi: 10.1530/RAF-24-0119. Print 2025 Apr 1.
PubMed 40232947
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Menstrual Cycle Stages on Physical Fitness in Female Athletes
- ClinicalTrials.gov ID
- NCT05576740
- Acronym / sponsor ID
- CD/77/2020
- Conditions
- Menstrual Cycle, Sports
- Keywords
- Menstrual cycle, Performance, Hormonal verification, Contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| natural cycle | – | 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 determinationIn 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 | – | 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, Other: Checking for correct use of contraceptive methodsIn 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 | – | 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 determinationIn 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determination of hormone level concentrationsDetermination 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 or surgery | artificial cycle, natural cycle, natural cycle with deficient luteal phase |
| Jump height determinationby 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 or surgery | artificial cycle, natural cycle, natural cycle with deficient luteal phase |
| Grip strength determinationmeasuring 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 or surgery | artificial cycle, natural cycle, natural cycle with deficient luteal phase |
| Flexibility determinationmeasurement 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 or surgery | artificial cycle, natural cycle, natural cycle with deficient luteal phase |
| Indirect maximum oxygen consumption determinationby 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. | Procedure or surgery | artificial cycle, natural cycle, natural cycle with deficient luteal phase |
| Sensory and pain threshold determinationby electrical muscle stimulator (Digitimer DS7A), during the early follicular phase, late follicular phase, and mid-luteal phase. | Device | artificial cycle, natural cycle, natural cycle with deficient luteal phase |
| Physical and mental symptoms associated with the menstrual cycleBy The Daily Record of Severity of Problems (DRSP) questionnaire, during a full menstrual cycle. | Other | artificial cycle, natural cycle, natural cycle with deficient luteal phase |
| Daily activityby accelerometer (GENEActiv) during a full menstrual cylcle: Wrist-worn device measuring accelerations as a measure of daily activity, in cpm, counts per minute. | Device | artificial cycle, natural cycle, natural cycle with deficient luteal phase |
| Biochemical parameters determinationDetermination 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 or surgery | artificial cycle, natural cycle, natural cycle with deficient luteal phase |
| Blood count determinationDetermination 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 or surgery | artificial cycle, natural cycle, natural cycle with deficient luteal phase |
| Body composition parameters determinationDetermination 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 or surgery | artificial cycle, natural cycle, natural cycle with deficient luteal phase |
| Vital signsDetermination of blood pressure (mmHg) and heart rate (bpm) at baseline, one minute and three minutes after the Course Navette test | Procedure or surgery | artificial cycle, natural cycle, natural cycle with deficient luteal phase |
| Checking for correct use of contraceptive methodsPre-test questions about possible forgetfulness or mishandling of the method | Other | artificial cycle |
| Urinary LH determinationUrine LH test strips are performed from day 8 of the cycle until positive. | Procedure or surgery | natural cycle, natural cycle with deficient luteal phase |
Primary outcome
Change in 17β-oestradiol concentration (in pg/mL)
Time frame: three times in a month
concentration of 17β-oestradiol in pg/mL
Change in T4 concentration (in mcg/dL)
Time frame: three times in a month
concentration of T4 in mcg/dL
Change in T3 concentration (in ng/dL)
Time frame: three times in a month
concentration of T3 in ng/dL
Change in cortisol concentration (in μg/dL)
Time frame: three times in a month
concentration of cortisol in μg/dL
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
Change in SHBG concentration (in nmol/L)
Time frame: three times in a month
concentration of sex hormone binding globulin (SHBG) in nmol/L
Change in free testosterone concentration (in pmol/L)
Time frame: three times in a month
Concentration of free testosterone in pmol/L
Change in progesterone concentration (in ng/mL)
Time frame: three times in a month
Concentration of progesterone, prolactin and total testosterone in ng/mL
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
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.
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.
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.
Change from baseline indirect maximum oxygen consumption
Time frame: three times in a month
by the Course Navette test
Change from baseline sensory and pain threshold
Time frame: 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
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.
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.
13 secondary outcomes
Change in iron concentration (in μg/dL)
Time frame: three times in a month
Change in transferrin concentration (in mg/dL)
Time frame: three times in a month
Change in ferritin concentration (in ng/mL)
Time frame: three times in a month
Change in hemoglobin concentration (in g/dL)
Time frame: three times in a month
Change in white blood cells and platelets concentration (in 10^3/μl)
Time frame: three times in a month
Change in hematocrit concentration (in %)
Time frame: three times in a month
Change in red blood cells concentration (in 10^6/μl)
Time frame: three times in a month
Change in weight, proteins, minerals and body fat mass in kg
Time frame: three times in a month
Change in Body Mass Index (BMI) in kg/m2
Time frame: three times in a month
Change in Basal metabolic rate in kcal
Time frame: three times in a month
Change in total body water in liters (L)
Time frame: three times in a month
Change in Blood pressure in mmHg
Time frame: three times in a month
Change in heart rate in bpm
Time frame: three times in a month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Derived from this study: PubMed 40232947Recacha-Ponce P, Suarez-Alcazar P, Hernando C, Salas-Medina P, Muriach M, Balino P, Guisado-Cuadrado I, Collado-Boira E. Hormonal balance, anovulatory cycles and luteal phase deficiency: exploring relationships between hematological variables, sex hormones and V̇O2max in athletes. Reprod Fertil. 2025 Apr 28;6(2):e240119. doi: 10.1530/RAF-24-0119. Print 2025 Apr 1.
- Individual participant dataSharing planned: Yes. The aim is to publish the results obtained in high impact journals.
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Heavy Menstrual Bleeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Recacha-Ponce, Midwife principal investigator
Universitat Jaume I
Eladio Collado-Boira, Doctor study director
Universitat Jaume I
Carlos Hernando-Domingo, Doctor study director
Universitat Jaume I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstrual Cycle and Sports, run by Universitat Jaume I at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 17β-oestradiol concentration (in pg/mL) (time frame: three times in a month). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05576740, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.