Clinical trial NCT05576740: Influence of Menstrual Cycle Stages on Female Athletes
Official title: Influence of Menstrual Cycle Stages on Physical Fitness in Female Athletes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menstrual Cycle
Sports
Keywords: Menstrual cycle
Performance
Hormonal verification
Contraception
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in 17β-oestradiol concentration (in pg/mL)
timeFrame: three times in a month
measure: Change in T4 concentration (in mcg/dL)
timeFrame: three times in a month
measure: Change in T3 concentration (in ng/dL)
timeFrame: three times in a month
measure: Change in cortisol concentration (in μg/dL)
timeFrame: three times in a month
measure: Change in TSH concentration (in mcUI/mL)
timeFrame: three times in a month
measure: Change in SHBG concentration (in nmol/L)
timeFrame: three times in a month
measure: Change in free testosterone concentration (in pmol/L)
timeFrame: three times in a month
measure: Change in progesterone concentration (in ng/mL)
timeFrame: three times in a month
measure: Change in LH and FSH concentration (in mUI/mL)
timeFrame: three times in a month
measure: Change from baseline jumping height
timeFrame: three times in a month
measure: Change from baseline grip strength
timeFrame: three times in a month
measure: Change from baseline flexibility
timeFrame: three times in a month
measure: Change from baseline indirect maximum oxygen consumption
timeFrame: three times in a month
measure: Change from baseline sensory and pain threshold
timeFrame: three times in a month
measure: Change from baseline physical and mental symptoms associated with the menstrual cycle by The Daily Record of Severity of Problems questionnaire
timeFrame: Duration of a full menstrual cycle (approximately 28 days)
measure: Change from baseline daily activity
timeFrame: Duration of a full menstrual cycle (approximately 28 days)
Secondary outcomes:
measure: Change in iron concentration (in μg/dL)
timeFrame: three times in a month
measure: Change in transferrin concentration (in mg/dL)
timeFrame: three times in a month
measure: Change in ferritin concentration (in ng/mL)
timeFrame: three times in a month
measure: Change in hemoglobin concentration (in g/dL)
timeFrame: three times in a month
measure: Change in white blood cells and platelets concentration (in 10^3/μl)
timeFrame: three times in a month
measure: Change in hematocrit concentration (in %)
timeFrame: three times in a month
measure: Change in red blood cells concentration (in 10^6/μl)
timeFrame: three times in a month
measure: Change in weight, proteins, minerals and body fat mass in kg
timeFrame: three times in a month
measure: Change in Body Mass Index (BMI) in kg/m2
timeFrame: three times in a month
measure: Change in Basal metabolic rate in kcal
timeFrame: three times in a month
measure: Change in total body water in liters (L)
timeFrame: three times in a month
measure: Change in Blood pressure in mmHg
timeFrame: three times in a month
measure: Change in heart rate in bpm
timeFrame: three times in a month
Other outcomes:
Locations:
city: Castelló de la Plana
country: Spain
facility: Jaume I University
state: Castellon
Study officials:
affiliation: Universitat Jaume I
name: Paula Recacha-Ponce, Midwife
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat Jaume I
name: Eladio Collado-Boira, Doctor
role: STUDY_DIRECTOR
affiliation: Universitat Jaume I
name: Carlos Hernando-Domingo, Doctor
role: STUDY_DIRECTOR
References: