Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
41 participants
OBSERVATIONAL
2022-03-16
2022-07-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
Blood count determination
Determination of concentration of hemoglobin (g/dL), red blood cells (10\^6/μL), hematocrit (%), white blood cells (10\^3/μl), platelets (10\^3/μl), during the early follicular phase, late follicular phase, and mid-luteal phase.
Body composition parameters determination
Determination of weight (kg), total body water (L), proteins (kg), minerals (kg), body fat mass (kg), body mass index (BMI) (kg/m2), basal metabolic rate (kcal) by Bioelectrical Impedance Analysis, during the early follicular phase, late follicular phase, and mid-luteal phase.
Vital signs
Determination of blood pressure (mmHg) and heart rate (bpm) at baseline, one minute and three minutes after the Course Navette test
Urinary LH determination
Urine LH test strips are performed from day 8 of the cycle until positive.
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.
Jump height determination
by Chronojump contact mat, determine five types of jump in centimeters: Squat jump without additional weight, Squat jump with 50% of body weight, Countermovement jump, Abalakov jump, and Drop jump, during the early follicular phase, late follicular phase, and mid-luteal phase.
Grip strength determination
measuring of changes in muscle strength by handgrip dynamometer in the hand to be tested (handgrip test) during the early follicular phase, late follicular phase, and mid-luteal phase. Three attempts on each hand.
Flexibility determination
measurement of changes in the range of motion of the hamstring musculature, by sit and reach test (cm), during the early follicular phase, late follicular phase, and mid-luteal phase. Three tries.
Indirect maximum oxygen consumption determination
by the Course Navette test, the indirect oxygen consumption is calculated using the formula: VO2max = (6xFA) - 27,4 (FA = Speed of the last stage of the test completed. It takes place during the early follicular phase, late follicular phase, and mid-luteal phase.
Sensory and pain threshold determination
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 cycle
By The Daily Record of Severity of Problems (DRSP) questionnaire, during a full menstrual cycle.
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.
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.
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.
Blood count determination
Determination of concentration of hemoglobin (g/dL), red blood cells (10\^6/μL), hematocrit (%), white blood cells (10\^3/μl), platelets (10\^3/μl), during the early follicular phase, late follicular phase, and mid-luteal phase.
Body composition parameters determination
Determination of weight (kg), total body water (L), proteins (kg), minerals (kg), body fat mass (kg), body mass index (BMI) (kg/m2), basal metabolic rate (kcal) by Bioelectrical Impedance Analysis, during the early follicular phase, late follicular phase, and mid-luteal phase.
Vital signs
Determination of blood pressure (mmHg) and heart rate (bpm) at baseline, one minute and three minutes after the Course Navette test
Checking for correct use of contraceptive methods
Pre-test questions about possible forgetfulness or mishandling of the method
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.
Jump height determination
by Chronojump contact mat, determine five types of jump in centimeters: Squat jump without additional weight, Squat jump with 50% of body weight, Countermovement jump, Abalakov jump, and Drop jump, during the early follicular phase, late follicular phase, and mid-luteal phase.
Grip strength determination
measuring of changes in muscle strength by handgrip dynamometer in the hand to be tested (handgrip test) during the early follicular phase, late follicular phase, and mid-luteal phase. Three attempts on each hand.
Flexibility determination
measurement of changes in the range of motion of the hamstring musculature, by sit and reach test (cm), during the early follicular phase, late follicular phase, and mid-luteal phase. Three tries.
Indirect maximum oxygen consumption determination
by the Course Navette test, the indirect oxygen consumption is calculated using the formula: VO2max = (6xFA) - 27,4 (FA = Speed of the last stage of the test completed. It takes place during the early follicular phase, late follicular phase, and mid-luteal phase.
Sensory and pain threshold determination
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 cycle
By The Daily Record of Severity of Problems (DRSP) questionnaire, during a full menstrual cycle.
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.
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.
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.
Blood count determination
Determination of concentration of hemoglobin (g/dL), red blood cells (10\^6/μL), hematocrit (%), white blood cells (10\^3/μl), platelets (10\^3/μl), during the early follicular phase, late follicular phase, and mid-luteal phase.
Body composition parameters determination
Determination of weight (kg), total body water (L), proteins (kg), minerals (kg), body fat mass (kg), body mass index (BMI) (kg/m2), basal metabolic rate (kcal) by Bioelectrical Impedance Analysis, during the early follicular phase, late follicular phase, and mid-luteal phase.
Vital signs
Determination of blood pressure (mmHg) and heart rate (bpm) at baseline, one minute and three minutes after the Course Navette test
Urinary LH determination
Urine LH test strips are performed from day 8 of the cycle until positive.
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.
Jump height determination
by Chronojump contact mat, determine five types of jump in centimeters: Squat jump without additional weight, Squat jump with 50% of body weight, Countermovement jump, Abalakov jump, and Drop jump, during the early follicular phase, late follicular phase, and mid-luteal phase.
Grip strength determination
measuring of changes in muscle strength by handgrip dynamometer in the hand to be tested (handgrip test) during the early follicular phase, late follicular phase, and mid-luteal phase. Three attempts on each hand.
Flexibility determination
measurement of changes in the range of motion of the hamstring musculature, by sit and reach test (cm), during the early follicular phase, late follicular phase, and mid-luteal phase. Three tries.
Indirect maximum oxygen consumption determination
by the Course Navette test, the indirect oxygen consumption is calculated using the formula: VO2max = (6xFA) - 27,4 (FA = Speed of the last stage of the test completed. It takes place during the early follicular phase, late follicular phase, and mid-luteal phase.
Sensory and pain threshold determination
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 cycle
By The Daily Record of Severity of Problems (DRSP) questionnaire, during a full menstrual cycle.
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.
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.
Interventions
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Blood count determination
Determination of concentration of hemoglobin (g/dL), red blood cells (10\^6/μL), hematocrit (%), white blood cells (10\^3/μl), platelets (10\^3/μl), during the early follicular phase, late follicular phase, and mid-luteal phase.
Body composition parameters determination
Determination of weight (kg), total body water (L), proteins (kg), minerals (kg), body fat mass (kg), body mass index (BMI) (kg/m2), basal metabolic rate (kcal) by Bioelectrical Impedance Analysis, during the early follicular phase, late follicular phase, and mid-luteal phase.
Vital signs
Determination of blood pressure (mmHg) and heart rate (bpm) at baseline, one minute and three minutes after the Course Navette test
Checking for correct use of contraceptive methods
Pre-test questions about possible forgetfulness or mishandling of the method
Urinary LH determination
Urine LH test strips are performed from day 8 of the cycle until positive.
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.
Jump height determination
by Chronojump contact mat, determine five types of jump in centimeters: Squat jump without additional weight, Squat jump with 50% of body weight, Countermovement jump, Abalakov jump, and Drop jump, during the early follicular phase, late follicular phase, and mid-luteal phase.
Grip strength determination
measuring of changes in muscle strength by handgrip dynamometer in the hand to be tested (handgrip test) during the early follicular phase, late follicular phase, and mid-luteal phase. Three attempts on each hand.
Flexibility determination
measurement of changes in the range of motion of the hamstring musculature, by sit and reach test (cm), during the early follicular phase, late follicular phase, and mid-luteal phase. Three tries.
Indirect maximum oxygen consumption determination
by the Course Navette test, the indirect oxygen consumption is calculated using the formula: VO2max = (6xFA) - 27,4 (FA = Speed of the last stage of the test completed. It takes place during the early follicular phase, late follicular phase, and mid-luteal phase.
Sensory and pain threshold determination
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 cycle
By The Daily Record of Severity of Problems (DRSP) questionnaire, during a full menstrual cycle.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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
18 Years
40 Years
FEMALE
Yes
Sponsors
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Universitat Jaume I
OTHER
Responsible Party
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Paula Recacha Ponce
Investigador principal
Principal Investigators
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Paula Recacha-Ponce, Midwife
Role: PRINCIPAL_INVESTIGATOR
Universitat Jaume I
Eladio Collado-Boira, Doctor
Role: STUDY_DIRECTOR
Universitat Jaume I
Carlos Hernando-Domingo, Doctor
Role: STUDY_DIRECTOR
Universitat Jaume I
Locations
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Jaume I University
Castellon, Castellon, Spain
Countries
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Other Identifiers
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CD/77/2020
Identifier Type: -
Identifier Source: org_study_id