Poly Cystic Ovarian SyndromeNCT06673901
Biomechanical Changes in Females with Poly Cystic Ovarian Syndrome
An observational study of Poly Cystic Ovarian Syndrome and Polycystic Ovary Syndrome (PCOS), run by Cairo University at 1 site in Egypt.
Trial summary
Polycystic ovarian syndrome (PCOS) is a prevalent endocrine disorder that causes an inversion of the normal luteinizing hormone (LH) to follicle-stimulating hormone (FSH) ratio. Females with PCOS also experience chronic inflammation. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Poly Cystic Ovarian Syndrome, Polycystic Ovary Syndrome (PCOS)
- What is being tested?
- Measurments
- Type of treatment
- Medical device
- How many people
- 95 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Apr 2023to 3 Sep 2024
- How long will I take part?
- 6 Months
- 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 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: This study enrolled 95 females (52 PCOS, 43 Controls) who agreed to participate in this research. They signed an informed consent after explaining the existence, purpose, and advantages of the study, notifying them of their right to refuse or withdraw at any time. Patients were excluded from the study if they suffered from skeletal deformities (one case), had previous spinal surgeries (one case), had leg length discrepancy (one case) and two cases received hormone replacement therapy
Who may be able to join
- Patients were referred by the gynecologist, based on Rotterdam PCOS Diagnostic Criteria in adults (14), having irregular menstrual cycles (less than 8 menstrual cycles/year or more than 35 days between cycles), painful menses and premenstrual abdominal bloating, and headaches.
Who cannot join
- were excluded from this study if they were obese with BMI > 30 Kg/m2 (obesity induces an increase in anterior pelvic tilt and increased sacral inclination) (15), suffered from musculoskeletal deformities, previous gynecological and spinal surgeries, spinal deformities, leg length discrepancy, orthopedic and neurological disorders, receive hormone replacement therapy (affect functional biomechanical properties by increasing tensile stiffness in the uterosacral ligament and decreasing it in the round ligament)
Trial locations and contacts
1 site in 1 country.
About this study
Polycystic ovarian syndrome (PCOS) is a prevalent endocrine disorder that causes an inversion of the normal luteinizing hormone (LH) to follicle-stimulating hormone (FSH) ratio. Females with PCOS also experience chronic inflammation. This hormonal imbalance and persistent inflammation can reduce muscle strength and mass. Consequently, this may affect the lumbopelvic muscles, potentially leading to postural abnormalities and spinopelvic misalignment.
Read the detailed description
1.1. Study design This was an observational case-control study. Participants This study enrolled 95 females (52 PCOS, 43 Controls) who agreed to participate in this research. They signed an informed consent after explaining the existence, purpose, and advantages of the study, notifying them of their right to refuse or withdraw at any time. Patients were excluded from the study if they suffered from skeletal deformities (one case), had previous spinal surgeries (one case), had leg length discrepancy (one case) and two cases received hormone replacement therapy
- Being tested
- Measurments
- Keywords
- Biomechanical Changes, Spinopelvic alignment, Polycystic Ovarian Syndrome, Hormonal Imbalance, Low-grade Inflammation
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeasurmentsDevice
Also called the inclinometer, PALM inclinometer, LH/FSH
Each angle was measured three times, and the mean was calculated to represent the data used for statistical analysis. The assessment position for all measurements was relaxed, comfortable standing position and wearing loose clothing, bare feet, and one foot apart between two feet on a level floor in the same room of the same building, at the same time of day. There was a fixed point in the wall, and the woman was instructed to look at it during the assessment; this point adjusts at the level of her eyes. No specific instructions were provided to the females regarding posture so that measurements during a normal standing position. Data was recorded in a data-collecting sheet.
| Study group | Role | What they receive |
|---|---|---|
| study group (A) | This study enrolled 95 females (52 PCOS, 43 Controls) who agreed to participate in this research. They signed an informed consent after explaining the existence, purpose, and advantages of the study, notifying them of their right to refuse or withdraw at any time. Patients were excluded from the study if they suffered from skeletal deformities (one case), had previous spinal surgeries (one case), had leg length discrepancy (one case) and two cases received hormone replacement therapy Receives: Device: Measurments | |
| control group (B). | Patients were referred by the gynecologist, based on Rotterdam PCOS Diagnostic Criteria in adults (14), having irregular menstrual cycles (less than 8 menstrual cycles/year or more than 35 days between cycles), painful menses and premenstrual abdominal bloating, and headaches. Forty-three healthy females not suffering from any gynecological condition were referred by a gynecologist and considered the Receives: Device: Measurments |
What is being measured
The primary outcome is the main question the study is designed to answer.
I) Pelvic tilt angle
While the female was upright, the physiotherapist recorded accurate measurements of the anterior superior iliac spine (ASIS) and posterior superior iliac spine (PSIS). As a result, the therapist adjusted the PALM inclinometer's one end arm on ASIS and the other on PSIS. As detected by the bubble level in the PALM inclinometer, the pelvic sagittal inclination angle was the angle between a horizontal line and a line passing between the ASIS and PSIS. The previous measurement was taken on the right and left sides of the pelvis. This approach has intra-tester solid reliability (ICC = 0.87) and accuracy and validity (17). The mean pelvic tilt angle value ranges from (13° ± 6°)
Measured: months 6
) Lumbar angle
Before the examination, the physiotherapist identifies and applies a skin marker on the spinous processes of the T12 and L5. The inclinometer dial measured the lumbar angle at zero degrees at the wall. Then put the inclinometer kindly but firmly into the inter-spinal spaces at T12 and position at L5, so obtaining the lumbar angle. Neutral values of the lumbar angle are 20º-40º (19). The baseline inclinometer was used with high intra-rater reliability (ICC=0.92) of the bubble inclinometer (20).
Measured: month 6
Secondary outcomes (1)
LH/FSH
Statistical analysis was conducted using SPSS for Windows, version 26 (SPSS, Inc., Chicago, IL). Variances and covariances were homogeneous (p> 0.05), as assessed by Levene's test of homogeneity of variances. Accordingly, parametric statistics were used. Quantitative variables were presented as mean ± standard deviation (X ± SD). An unpaired t-test was used to compare the physical characteristics of both groups. One-way between-subject MANOVA was conducted to determine the differences between both groups in the degree of pelvic inclination, lumbar curve angle, and hormones (LH \&FSH). Pearson's correlation coefficient was used to investigate the relationship between pelvic inclination, lumbar curve angle, and hormones (LH \&FSH) in females with PCOS. The alpha level was set at 0.05, and the correlation coefficients were interpreted as 0-0.1 = extremely low, 0.10-0.30 = low, 0.30-0.50 = moderate, 0.50-0.70 = high, 0.70-0.90 = extremely high, and 0.90-1.0 = strong
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start3 Apr 2023
- Primary completion3 Aug 2024
- Study completion3 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poly Cystic Ovarian SyndromeStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 95 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rovan mohamed saad elbesh, Misr University for Science and Technology
- Investigators
- rovan m saad, PHD, Principal investigator, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673901
- Sponsor's protocol ID
- NP.T.REC/012/001889
- Status last verified
- Nov 2024
- First submitted
- 17 Sep 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Changes in Females with Poly Cystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT06673901
- Acronym / sponsor ID
- NP.T.REC/012/001889
- Keywords
- Biomechanical Changes, Spinopelvic alignment, Polycystic Ovarian Syndrome, Hormonal Imbalance, Low-grade Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 3 Aug 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 5 Nov 2024 (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.
Polycystic ovarian syndrome (PCOS) is a prevalent endocrine disorder that causes an inversion of the normal luteinizing hormone (LH) to follicle-stimulating hormone (FSH) ratio. Females with PCOS also experience chronic inflammation. This hormonal imbalance and persistent inflammation can reduce muscle strength and mass. Consequently, this may affect the lumbopelvic muscles, potentially leading to postural abnormalities and spinopelvic misalignment.
Detailed description
1.1. Study design This was an observational case-control study. Participants This study enrolled 95 females (52 PCOS, 43 Controls) who agreed to participate in this research. They signed an informed consent after explaining the existence, purpose, and advantages of the study, notifying them of their right to refuse or withdraw at any time. Patients were excluded from the study if they suffered from skeletal deformities (one case), had previous spinal surgeries (one case), had leg length discrepancy (one case) and two cases received hormone replacement therapy
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group (A) | – | Device: MeasurmentsThis study enrolled 95 females (52 PCOS, 43 Controls) who agreed to participate in this research. They signed an informed consent after explaining the existence, purpose, and advantages of the study, notifying them of their right to refuse or withdraw at any time. Patients were excluded from the study if they suffered from skeletal deformities (one case), had previous spinal surgeries (one case), had leg length discrepancy (one case) and two cases received hormone replacement therapy |
| control group (B). | – | Device: MeasurmentsPatients were referred by the gynecologist, based on Rotterdam PCOS Diagnostic Criteria in adults (14), having irregular menstrual cycles (less than 8 menstrual cycles/year or more than 35 days between cycles), painful menses and premenstrual abdominal bloating, and headaches. Forty-three healthy females not suffering from any gynecological condition were referred by a gynecologist and considered the |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study enrolled 95 females (52 PCOS, 43 Controls) who agreed to participate in this research. They signed an informed consent after explaining the existence, purpose, and advantages of the study, notifying them of their right to refuse or withdraw at any time. Patients were excluded from the study if they suffered from skeletal deformities (one case), had previous spinal surgeries (one case), had leg length discrepancy (one case) and two cases received hormone replacement therapy
Key inclusion criteria (1 listed)
- Patients were referred by the gynecologist, based on Rotterdam PCOS Diagnostic Criteria in adults (14), having irregular menstrual cycles (less than 8 menstrual cycles/year or more than 35 days between cycles), painful menses and premenstrual abdominal bloating, and headaches.
Key exclusion criteria (1 listed)
- were excluded from this study if they were obese with BMI > 30 Kg/m2 (obesity induces an increase in anterior pelvic tilt and increased sacral inclination) (15), suffered from musculoskeletal deformities, previous gynecological and spinal surgeries, spinal deformities, leg length discrepancy, orthopedic and neurological disorders, receive hormone replacement therapy (affect functional biomechanical properties by increasing tensile stiffness in the uterosacral ligament and decreasing it in the round ligament)
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 |
|---|---|---|
| MeasurmentsAlso: the inclinometer, PALM inclinometer, LH/FSHEach angle was measured three times, and the mean was calculated to represent the data used for statistical analysis. The assessment position for all measurements was relaxed, comfortable standing position and wearing loose clothing, bare feet, and one foot apart between two feet on a level floor in the same room of the same building, at the same time of day. There was a fixed point in the wall, and the woman was instructed to look at it during the assessment; this point adjusts at the level of her eyes. No specific instructions were provided to the females regarding posture so that measurements during a normal standing position. Data was recorded in a data-collecting sheet. | Device | control group (B)., study group (A) |
Primary outcome
I) Pelvic tilt angle
Time frame: months 6
While the female was upright, the physiotherapist recorded accurate measurements of the anterior superior iliac spine (ASIS) and posterior superior iliac spine (PSIS). As a result, the therapist adjusted the PALM inclinometer's one end arm on ASIS and the other on PSIS. As detected by the bubble level in the PALM inclinometer, the pelvic sagittal inclination angle was the angle between a horizontal line and a line passing between the ASIS and PSIS. The previous measurement was taken on the right and left sides of the pelvis. This approach has intra-tester solid reliability (ICC = 0.87) and accuracy and validity (17). The mean pelvic tilt angle value ranges from (13° ± 6°)
) Lumbar angle
Time frame: month 6
Before the examination, the physiotherapist identifies and applies a skin marker on the spinous processes of the T12 and L5. The inclinometer dial measured the lumbar angle at zero degrees at the wall. Then put the inclinometer kindly but firmly into the inter-spinal spaces at T12 and position at L5, so obtaining the lumbar angle. Neutral values of the lumbar angle are 20º-40º (19). The baseline inclinometer was used with high intra-rater reliability (ICC=0.92) of the bubble inclinometer (20).
1 secondary outcome
LH/FSH
Time frame: month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
rovan m saad, PHD principal investigator
Misr University for Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Poly Cystic Ovarian Syndrome and Polycystic Ovary Syndrome (PCOS), run by Cairo University at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
I) Pelvic tilt angle (time frame: months 6). The study lists 2 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 5 Nov 2024.