Menstrual CycleNCT05088122
Hormonal Effect of Different Menstrual Phases on Dynamic Balance in Postpubertal Females
An observational study of Menstrual Cycle, run by Cairo University.
Trial summary
High rate of injuries detected during certain periods of menstrual cycle, raised the suggestion of the effecacy of the female sex hormones on soft tissue and neuromuscular control with subsequent deterioration of postural stability and high injury prevalence in post pubertal females so the aim of the present study is… Read more about this study
- Who is it for?
- Ages 16 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cycle
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2021to 25 Jan 2022
- 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 16 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Thirty-six, healthy postpubertal females , their ages will be ranged from 16-25 and BMI will be ranged from 18-27kg/m2, with regular menstrual cycle and with no any health condition that can affect the balance performance
Who may be able to join
- All females will be virginal.
- Their ages will range from 15-25 years.
- Their body mass index (BMI) will range from 18-27 kg/m2.
- All females will have regular menstrual cycle within average of 28 days.
Who cannot join
- Females having menstrual irregularity.
- Use of oral contraceptives or any hormonal treatment in the previous six months before participate in this study.
- History of lower extremity injury, surgery or pain during ADL.
- Females having any vestibular problems , otitis media, labyrinthitis or any inner ear problems that affect balance.
Trial locations and contacts
No sites are listed yet.
Hager M.E. Abd-elaziz, Demonstrator contact
About this study
Official title: Hormonal Effect Of Different Phases Of Menstrual Cycle On Postural Stability In Postpubertal Females: A Cross Sectional Repeated Measure Design
High rate of injuries detected during certain periods of menstrual cycle, raised the suggestion of the effecacy of the female sex hormones on soft tissue and neuromuscular control with subsequent deterioration of postural stability and high injury prevalence in post pubertal females so the aim of the present study is to investigate the effect of female sex hormones on postural stability in post pubertal females.
Read the detailed description
Thirty-six post pubertal females will participate in this study. They will be selected from students and graduates of Faculty of Physical Therapy, Deraya University and they will be assigned into one group. Postural stability assessment will be carried out throughout three menstrual cycle phases, early follicular, ovulation and mid luteal phases by Biodex balance system. The timing of menstrual cycle phases will be determined by measuring serum estradiol and progesterone level. The exact time of ovulation will be determined by urine lutenizing hormone ovulatory strip test.
- Conditions
- Menstrual Cycle
- Being tested
- no intervention
- Keywords
- Sex hormones, Postural stability, Menstrual cycle.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention, not applicable
| Study group | Role | What they receive |
|---|---|---|
| one group | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum estradiol level
used for accurate timing of menstrual cycle phases, follicular and midluteal.
Measured: two months
Anetro-posterior stability index
Indicator for dynamic postural stability
Measured: two months
Medio-lateral stability index
Indicator for dynamic postural stability
Measured: two months
Overall stability index
Indicator for dynamic postural stability
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start15 Oct 2021 (estimated)
- Primary completion25 Dec 2021 (estimated)
- Study completion25 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual CycleStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager Mohey Eldien Abdel Aziz Mahmoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088122
- Sponsor's protocol ID
- P.T.REC/012/003102
- Status last verified
- Oct 2021
- First submitted
- 8 Oct 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormonal Effect Of Different Phases Of Menstrual Cycle On Postural Stability In Postpubertal Females: A Cross Sectional Repeated Measure Design
- ClinicalTrials.gov ID
- NCT05088122
- Acronym / sponsor ID
- P.T.REC/012/003102
- Conditions
- Menstrual Cycle
- Keywords
- Sex hormones, Postural stability, Menstrual cycle.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (estimated)
- Primary completion
- 25 Dec 2021 (estimated)
- Study completion
- 25 Jan 2022 (estimated)
- First posted
- 21 Oct 2021 (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.
High rate of injuries detected during certain periods of menstrual cycle, raised the suggestion of the effecacy of the female sex hormones on soft tissue and neuromuscular control with subsequent deterioration of postural stability and high injury prevalence in post pubertal females so the aim of the present study is to investigate the effect of female sex hormones on postural stability in post pubertal females.
Detailed description
Thirty-six post pubertal females will participate in this study. They will be selected from students and graduates of Faculty of Physical Therapy, Deraya University and they will be assigned into one group. Postural stability assessment will be carried out throughout three menstrual cycle phases, early follicular, ovulation and mid luteal phases by Biodex balance system. The timing of menstrual cycle phases will be determined by measuring serum estradiol and progesterone level. The exact time of ovulation will be determined by urine lutenizing hormone ovulatory strip test.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one group | – | Other: no intervention |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Thirty-six, healthy postpubertal females , their ages will be ranged from 16-25 and BMI will be ranged from 18-27kg/m2, with regular menstrual cycle and with no any health condition that can affect the balance performance
Key inclusion criteria (4 listed)
- All females will be virginal.
- Their ages will range from 15-25 years.
- Their body mass index (BMI) will range from 18-27 kg/m2.
- All females will have regular menstrual cycle within average of 28 days.
Key exclusion criteria (4 listed)
- Females having menstrual irregularity.
- Use of oral contraceptives or any hormonal treatment in the previous six months before participate in this study.
- History of lower extremity injury, surgery or pain during ADL.
- Females having any vestibular problems , otitis media, labyrinthitis or any inner ear problems that affect balance.
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 |
|---|---|---|
| no interventionno intervention, not applicable | Other | one group |
Primary outcome
serum estradiol level
Time frame: two months
used for accurate timing of menstrual cycle phases, follicular and midluteal.
Anetro-posterior stability index
Time frame: two months
Indicator for dynamic postural stability
Medio-lateral stability index
Time frame: two months
Indicator for dynamic postural stability
Overall stability index
Time frame: two months
Indicator for dynamic postural stability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Individual participant dataSharing planned: Yes
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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.
Hager M.E. Abd-elaziz, Demonstrator contact
Questions about this trial
What is this clinical trial studying?
An observational study of Menstrual Cycle, run by Cairo University.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manal A. el-shafei, lecturer (00201220664518, manalpt1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum estradiol level (time frame: two months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2021.