PCOSNCT02402413
Ultrasound Three-dimensional Characterization of Ovarian Morphology in Women With Polycystic Ovary Syndrome (PCOS)
A study testing Ultrasound, Determination of concentrations of androgens and Three dimensional ultrasound probe in people with PCOS and Hyperandrogenism, run by University of Cagliari.
Trial summary
Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders occurring in women of reproductive age. PCOS is considered a syndrome of ovarian dysfunction that is characterized by the heterogeneous clinical manifestation of infrequent or absent menstrual cycles, hyperandrogenism, and polycystic… Read more about this study
- Who is it for?
- Ages 15 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS, Hyperandrogenism
- What is being tested?
- Ultrasound, Determination of concentrations of androgens and Three dimensional ultrasound probe
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Dec 2016
- Phase
- Interventional
- 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 15 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Self-reported history of infrequent or absent menstrual cycles and/or PCOS ultrasound feature and/or clinical or biochemical hyperandrogenism
- Did not take hormonal contraception, fertility therapies, or insulin sensitizers in the three months prior to enrollment
Who cannot join
- Pregnancy
About this study
Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders occurring in women of reproductive age. PCOS is considered a syndrome of ovarian dysfunction that is characterized by the heterogeneous clinical manifestation of infrequent or absent menstrual cycles, hyperandrogenism, and polycystic ovarian morphology.
An important ultrasound parameter is the ratio stroma/ovary, the ratio of the volume, evaluated in two-dimensional ultrasound, of the stroma, that secrete androgen, and the ovary. It has been shown that when this ratio is higher than a third the levels of circulating androgens and high. Aim of the present study is to assess whether this ratio, determined with three-dimensional ultrasound, is correlated to the increase of androgens.
- Conditions
- PCOS, Hyperandrogenism
- Being tested
- Ultrasound, Determination of concentrations of androgens, Three dimensional ultrasound probe
- Medical subject headings
- Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
Also called Ultrasound evaluation of ovarian morphology
The patients will be subjected to ultrasound bi-dimensional or three-dimensional. Will Be calculated the ratio stroma/volume with both methods
Determination of concentrations of androgensProcedure or surgery
Determination of concentrations of serum levels of circulating androgens
Three dimensional ultrasound probeDevice
Capture of ovarian three dimensional volumes
| Study group | Role | What they receive |
|---|---|---|
| PCOS women | Experimental | Not described Receives: Procedure: Ultrasound; Procedure: Determination of concentrations of androgens; Device: Three dimensional ultrasound probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Androgens serum levels in women with ultrasound morphological PCO
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startJun 2016
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PCOSStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Angioni, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402413
- Sponsor's protocol ID
- PCOSCA
- Status last verified
- Mar 2016
- First submitted
- 18 Mar 2015
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Fulghesu AM, Ciampelli M, Belosi C, Apa R, Pavone V, Lanzone A. A new ultrasound criterion for the diagnosis of polycystic ovary syndrome: the ovarian stroma/total area ratio. Fertil Steril. 2001 Aug;76(2):326-31. doi: 10.1016/s0015-0282(01)01919-7.
PubMed 11476780
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Three-dimensional Characterization of Ovarian Morphology in Women With Polycystic Ovary Syndrome (PCOS)
- ClinicalTrials.gov ID
- NCT02402413
- Acronym / sponsor ID
- PCOSCA
- Conditions
- PCOS, Hyperandrogenism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 30 Mar 2015 (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.
Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders occurring in women of reproductive age. PCOS is considered a syndrome of ovarian dysfunction that is characterized by the heterogeneous clinical manifestation of infrequent or absent menstrual cycles, hyperandrogenism, and polycystic ovarian morphology.
An important ultrasound parameter is the ratio stroma/ovary, the ratio of the volume, evaluated in two-dimensional ultrasound, of the stroma, that secrete androgen, and the ovary. It has been shown that when this ratio is higher than a third the levels of circulating androgens and high. Aim of the present study is to assess whether this ratio, determined with three-dimensional ultrasound, is correlated to the increase of androgens.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCOS women | Experimental | Procedure: Ultrasound, Procedure: Determination of concentrations of androgens, Device: Three dimensional ultrasound probe |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Self-reported history of infrequent or absent menstrual cycles and/or PCOS ultrasound feature and/or clinical or biochemical hyperandrogenism
- Did not take hormonal contraception, fertility therapies, or insulin sensitizers in the three months prior to enrollment
Key exclusion criteria (1 listed)
- Pregnancy
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 |
|---|---|---|
| UltrasoundAlso: Ultrasound evaluation of ovarian morphologyThe patients will be subjected to ultrasound bi-dimensional or three-dimensional. Will Be calculated the ratio stroma/volume with both methods | Procedure or surgery | PCOS women |
| Determination of concentrations of androgensDetermination of concentrations of serum levels of circulating androgens | Procedure or surgery | PCOS women |
| Three dimensional ultrasound probeCapture of ovarian three dimensional volumes | Device | PCOS women |
Primary outcome
Androgens serum levels in women with ultrasound morphological PCO
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
- Results publication: PubMed 11476780Fulghesu AM, Ciampelli M, Belosi C, Apa R, Pavone V, Lanzone A. A new ultrasound criterion for the diagnosis of polycystic ovary syndrome: the ovarian stroma/total area ratio. Fertil Steril. 2001 Aug;76(2):326-31. doi: 10.1016/s0015-0282(01)01919-7.
Related trials for PCOS
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound, Determination of concentrations of androgens and Three dimensional ultrasound probe in people with PCOS and Hyperandrogenism, run by University of Cagliari.
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 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 9 Mar 2016. 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?
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?
Androgens serum levels in women with ultrasound morphological PCO (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02402413, which also lists 1 linked publication.
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 9 Mar 2016.