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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05928650
Other study ID # P.T.REC/012/004550
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date July 31, 2023

Study information

Verified date August 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to compare between sprinters and long marathon in menstrual characteristics and serum estradiol level.


Description:

Menstrual function and dysfunction conversations have long been stigmatized both in the general population and in sport settings (O'Flynn, 2006). However, Discussions of menstruation in the sport context often focuses on the impact of physical menstrual symptoms and dysfunction on activities such as training and sport performance (Bruinvels et al., 2016; Knowles et al., 2019). In addition, no study had been compare between sprinters and long-marathon runners in menstrual characteristics and estradiol level. Therefore, the purpose of this study to compare between sprinters and long marathon in menstrual characteristics and serum estradiol level.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date July 31, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers
Gender Female
Age group 16 Years to 19 Years
Eligibility Inclusion Criteria: - Virginal females. - Their age ranged from 16 to 19years. - All females had the same socio-economic status. For athletic groups only: - They have been starting the practice of sport at least one year before the onset of menarche. Exclusion Criteria: - Females who had been used oral contraceptives or any hormonal treatment in the previous six months. - Smoking. - History of chronic disease. - Having any psychiatric problems. For athletic groups only: - injured females who were absent from training for at least three months.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Evaluation of menstrual function
Evaluation of serum estradiol levels and menstrual history characteristics between sprinters, long marathon runners and non-athletes.

Locations

Country Name City State
Egypt Faculty of Physical therapy, Cairo University Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum estradiol level Blood samples were obtained on the 2nd day of the menstrual cycle at 10.00 a.m. following overnight fasting and rest. The athletic females were instructed to refrain from performing strenuous exercise on the day of sampling. Blood samples were separated and stored at -80°C till analysis of serum estradiol levels. Serum estradiol levels were measured to evaluate the menstrual function. The manufacturer indicated the following reference intervals for healthy females: Estradiol 40-350 pg/ml. 3 months
Primary Menstrual history characteristics The age at menarche (in years), the number of menstrual cycles in the past year, and the length of menstrual cycles (in days) were collected through a self-administered questionnaire to evaluate the menstrual status of each female participant. 3 months
Primary Age of participation to sport It was taken in years from each female athlete through a self-administered questionnaire. 3 months
Primary Weekly training workload It was taken in hours per week from each female athlete through a self-administered questionnaire. 3 months
Primary Training experience The training experience of the athlete was then calculated by subtracting her age of participation in sport from her chronological age. 3 months
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