Polycystic OvaryNCT03819998
Serum Fetuin Level in Polycystic Ovary Syndrome
An observational study of Polycystic Ovary, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
polycystic ovary syndrome is a common gynecological problem Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary
- What is being tested?
- measurement of Fetuin-A level in serum
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2019to 5 Feb 2020
- 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 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women who have PCOS and have symptoms of hyperandrogenism and irregular cycles
Who may be able to join
- women who have PCOS in group 1 and who donnot have PCOS in group 2 with age between 20 -42 years
Who cannot join
- women above 42 years old
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Algazeerah and Kasralainy hospital
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
About this study
Official title: Serum Fetuin Level as a Marker in Polycystic Ovary Syndrome
polycystic ovary syndrome is a common gynecological problem
Read the detailed description
Understanding the pathophysiology and the cause is of much importance for proper management of this problem
- Conditions
- Polycystic Ovary
- Being tested
- measurement of Fetuin-A level in serum
- 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.
measurement of Fetuin-A level in serumDiagnostic test
Also called Fwtuin A level
Fetuin A level will be measured in blood of the PCOS women
| Study group | Role | What they receive |
|---|---|---|
| PCOS group | women who have PCOS Receives: Diagnostic Test: measurement of Fetuin-A level in serum | |
| control group | women who donnot have PCOS Receives: Diagnostic Test: measurement of Fetuin-A level in serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of women who will have high level of fetuin A and has PCOS
Evaluation of women who have PCOS in relation to fetuin A level
Measured: within a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start30 Jan 2019
- Primary completion1 Feb 2020 (estimated)
- Study completion5 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic OvaryStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University, National Research Centre, Egypt
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819998
- Sponsor's protocol ID
- Fetuin
- Status last verified
- Aug 2019
- First submitted
- 25 Jan 2019
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Fetuin Level as a Marker in Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT03819998
- Acronym / sponsor ID
- Fetuin
- Conditions
- Polycystic Ovary
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Cairo University, National Research Centre, Egypt
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 5 Feb 2020 (estimated)
- First posted
- 29 Jan 2019 (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 ovary syndrome is a common gynecological problem
Detailed description
Understanding the pathophysiology and the cause is of much importance for proper management of this problem
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS group | – | Diagnostic Test: measurement of Fetuin-A level in serumwomen who have PCOS |
| control group | – | Diagnostic Test: measurement of Fetuin-A level in serumwomen who donnot have PCOS |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women who have PCOS and have symptoms of hyperandrogenism and irregular cycles
Key inclusion criteria (1 listed)
- women who have PCOS in group 1 and who donnot have PCOS in group 2 with age between 20 -42 years
Key exclusion criteria (1 listed)
- women above 42 years old
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 |
|---|---|---|
| measurement of Fetuin-A level in serumAlso: Fwtuin A levelFetuin A level will be measured in blood of the PCOS women | Diagnostic test | PCOS group, control group |
Primary outcome
The number of women who will have high level of fetuin A and has PCOS
Time frame: within a week
Evaluation of women who have PCOS in relation to fetuin A level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
Related trials for Polycystic Ovary
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
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.
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 Polycystic Ovary, run by Aljazeera Hospital 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: status not confirmed, as of the sponsor's last update on 6 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Alalfy, PhD (01002611058, mahmoudalalfy@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of women who will have high level of fetuin A and has PCOS (time frame: within a week). 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 6 Aug 2019.