- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05928650
Comparison of Menstrual Function Among Sprinters, Long Marathon Runners, and Non-Athletic Females
August 30, 2023 updated by: Doaa A. Osman, Cairo University
Comparison of Menstrual Function Among Sprinters, Long Marathon Runners, and Non-athletic Females: An Observational Study
The purpose of this study is to compare between sprinters and long marathon in menstrual characteristics and serum estradiol level.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
42
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Doaa Osman
- Phone Number: 5792245
- Email: Doaa.osman@cu.edu.eg
Study Contact Backup
- Name: Mai Mohamed Ali Shehata
- Phone Number: 0 112 653 3836
- Email: mai_shehata@cu.edu.eg
Study Locations
-
-
-
Giza, Egypt
- Faculty of Physical Therapy, Cairo 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
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Egyptian sprinters, long marathon runners, and non-athletic females
Description
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 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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Sprinters
|
Evaluation of serum estradiol levels and menstrual history characteristics between sprinters, long marathon runners and non-athletes.
|
Long marathon runners
|
Evaluation of serum estradiol levels and menstrual history characteristics between sprinters, long marathon runners and non-athletes.
|
Non-athletic Females
|
Evaluation of serum estradiol levels and menstrual history characteristics between sprinters, long marathon runners and non-athletes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serum estradiol level
Time Frame: 3 months
|
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
|
Menstrual history characteristics
Time Frame: 3 months
|
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
|
Age of participation to sport
Time Frame: 3 months
|
It was taken in years from each female athlete through a self-administered questionnaire.
|
3 months
|
Weekly training workload
Time Frame: 3 months
|
It was taken in hours per week from each female athlete through a self-administered questionnaire.
|
3 months
|
Training experience
Time Frame: 3 months
|
The training experience of the athlete was then calculated by subtracting her age of participation in sport from her chronological age.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Doaa Osman, Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
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)
May 1, 2023
Primary Completion (Actual)
July 31, 2023
Study Completion (Actual)
July 31, 2023
Study Registration Dates
First Submitted
June 26, 2023
First Submitted That Met QC Criteria
June 26, 2023
First Posted (Actual)
July 3, 2023
Study Record Updates
Last Update Posted (Estimated)
August 31, 2023
Last Update Submitted That Met QC Criteria
August 30, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/004550
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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