Polycystic OvaryNCT02087410
Serum Ghrelin in Polycystic Ovary Syndrome
An observational study of Polycystic Ovary, run by amr hesham el etreby at 1 site in Egypt.
Trial summary
measuring serum gherlin in polycystic ovary syndrome patients and compare it to healthy levels Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2014to Dec 2014
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Forty two patients with polycystic ovarian syndrome and forty two healthy subjects will be recruited from the outpatient clinic Ain Shams University Maternity Hospital.
Who may be able to join
- At least 12 months of infertility.
- Patients with polycystic ovarian syndrome according to Rotterdam criteria:
Who cannot join
- Patients with hyperprolactinemia
- Patients with Cushing's syndrome
- Patients with Congenital or non-classical adrenal hyperplasia
- Patients with hormone secreting tumors.
- Patients with hormonal treatment in the last 3 months.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Maternity Hospital
Cairo, Cairo Governorate
amr h eletreby, resident, 0096659000850, mhmdzdn@Gmail.com
amr h eletreby, resident, 00966566255584, eletreby.amr@Gmail.com
About this study
Official title: Ghrelin in Polycystic Ovary Syndrome
measuring serum gherlin in polycystic ovary syndrome patients and compare it to healthy levels
Read the detailed description
two groups one healthy and other with pco measure ghrelin level in both of them to find relation between pco and ghrelin
- Conditions
- Polycystic Ovary
- 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.
| Study group | Role | What they receive |
|---|---|---|
| study | patients with polycystic ovary syndrome | |
| control | healthy patients serves as control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
relationships between circulating ghrelin and the clinical and biochemical manifestations of PCOS
Analysis of levels of ghrelin in study group
Measured: after 6 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2014 (estimated)
- Study completionDec 2014 (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
- Cross-sectional
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- amr hesham el etreby
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, amr hesham el etreby, Ain Shams University
- Investigators
- amr eletrby, MBBCH, Principal investigator, ain shams universty maternity hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087410
- Sponsor's protocol ID
- Ghrelin
- Status last verified
- Mar 2014
- First submitted
- 12 Mar 2014
- Last updated
- 14 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ghrelin in Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT02087410
- Acronym / sponsor ID
- Ghrelin
- Conditions
- Polycystic Ovary
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- amr hesham el etrebyUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 14 Mar 2014 (estimated)
- 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.
measuring serum gherlin in polycystic ovary syndrome patients and compare it to healthy levels
Detailed description
two groups one healthy and other with pco measure ghrelin level in both of them to find relation between pco and ghrelin
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study | – | –patients with polycystic ovary syndrome |
| control | – | –healthy patients serves as control group |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Forty two patients with polycystic ovarian syndrome and forty two healthy subjects will be recruited from the outpatient clinic Ain Shams University Maternity Hospital.
Key inclusion criteria (2 listed)
- At least 12 months of infertility.
- Patients with polycystic ovarian syndrome according to Rotterdam criteria:
Key exclusion criteria (5 listed)
- Patients with hyperprolactinemia
- Patients with Cushing's syndrome
- Patients with Congenital or non-classical adrenal hyperplasia
- Patients with hormone secreting tumors.
- Patients with hormonal treatment in the last 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
relationships between circulating ghrelin and the clinical and biochemical manifestations of PCOS
Time frame: after 6 monthes
Analysis of levels of ghrelin in study group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2014.
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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.
amr eletrby, MBBCH principal investigator
ain shams universty maternity hospital
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 amr hesham el etreby 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 2 inclusion and 5 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 14 Mar 2014. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relationships between circulating ghrelin and the clinical and biochemical manifestations of PCOS (time frame: after 6 monthes). 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 14 Mar 2014.