Polycystic Ovary SyndromeNCT05785507
PriskA Pilot Study
An observational study of Polycystic Ovary Syndrome, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Background of the study: With a prevalence up to 15%, polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. Women with PCOS present with diverse features, including reproductive features such as irregular menstrual cycles, subfertility, hirsutism and pregnancy… Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- PriskA tool
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2023to 4 Dec 2023
- 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 45 years
- Women only
- Child, Adult
Study population: Women with symptoms of PCOS who are referred to the Department of Reproductive Endocrinology at the Erasmus University Medical Center Rotterdam, and are undergoing a standardized screening (COLA screening, which stands for: (menstrual) Cycle problems, Oligomenorrhea and Amenorrhea) will be asked to participate. The COLA screening is part of standard clinical care. Women with one or more symptoms of PCOS will be included in the study. Women who eventually getting the diagnosis PCOS by standard screening will be labelled as cases and women who have one PCOS symptom and did not get the diagnosis PCOS will be labelled as non-PCOS.
Who may be able to join
- Women with signs and symptoms of PCOS, including: irregular or absent menstrual cycle, hirsutism or polycystic ovarian morphology who undergoing a standardized screening (COLA screening)
- Age range 16-45 years
- Sufficient command of the Dutch language
- Signed written informed consent
Who cannot join
- Documented ongoing pregnancy
- Malignancy (documented malignancy, documentation of current radiation therapy or chemotherapy in medical record)
- If transvaginal ultrasound is not possible or it is inappropriate
- Not willing to share clinical data with Roche and Evidencio
- Use of hormonal medication in the past three months, including hormonal IUD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Test the PCOS Risk Algorithm (PriskA)
Background of the study:
With a prevalence up to 15%, polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. Women with PCOS present with diverse features, including reproductive features such as irregular menstrual cycles, subfertility, hirsutism and pregnancy complications, metabolic features such as obesity, insulin resistance, metabolic syndrome, pre-diabetes, type 2 diabetes and cardiovascular factors, and psychological features such as anxiety and depression. Because of the reproductive, metabolic and cardiovascular risk factors it is important to screen and inform these women. However, up to 70% of the affected women remain undiagnosed. In academic hospitals (tertiary care) the diagnosis PCOS will rarely be missed by gynecologists. However, in peripheral hospitals or for internal medicine physicians, PCOS and its criteria are less well known.
Read more
Therefore, the PCOS risk algorithm (PriskA), a digital tool to use in the assessment of PCOS in patients with signs and symptoms of PCOS, is developed. To exclude patients with a WHO I status, the tool exclude women with low Luteinizing Hormone (LH) and low Follicle-Stimulating Hormone (FSH) in advance. Women with LH and FSH within the normal range will be used in the algorithm for further assessment. The algorithm uses clinical data including age, BMI and information about irregular menstrual cycle in combination with anti-Mullerian hormone (AMH), testosterone and Sex Hormone Binding Globulin (SHBG) to generate a risk score ranging from 0-1. Women having a risk score below 0.2 are considered having a low risk of having PCOS, women with a risk score 0.2-0.8 are considered having a moderate risk of having PCOS and women with a risk score above 0.8 have a high risk of having PCOS.
Objective of the study:
In this study we aim to assess the validity of the PriskA algorithm to diagnose PCOS in a pilot study with patients presenting with signs and symptoms of PCOS. The study also aims to collect information on the user experience from the clinicians and to provide useful information to support the design of a validation study.
Study design:
This study will be a prospective, mono-center observational pilot study and it will be conducted at the Department of Reproductive Endocrinology at the Erasmus University Medical Center Rotterdam, the Netherlands. We estimate that the study will be completed within one year.
Study population:
Women with symptoms of PCOS who are referred to the Department of Reproductive Endocrinology at the Erasmus University Medical Center Rotterdam, and are undergoing a standardized screening (COLA screening, which stands for: (menstrual) Cycle problems, Oligomenorrhea and Amenorrhea). The COLA screening is part of standard clinical care. Women with one or more symptoms of PCOS will be included in the study. Women who eventually getting the diagnosis PCOS by standard screening will be labelled as cases and women who have one PCOS symptom and did not get the diagnosis PCOS will be labelled as controls.
Primary study parameters/outcome of the study:
The validity of the PriskA tool to diagnose PCOS, by assessing the sensitivity and specificity of the risk probabilities of 0.2 and 0.8.Parameters that will be used:
- Testosterone level in serum (using Elecsys using Cobas 6000)
- SHBG level in serum (using Elecsys using Cobas 6000).
- AMH level in serum (using Elecsys using Cobas 6000).
- LH level in serum (using Elecsys using Cobas 6000)
- FSH level in serum (using Elecsys using Cobas 6000)
- Cycle information
- Age
- BMI
Secondary study parameters/outcome of the study:
A secondary study parameter is to assess the number (percentage) and characteristics of patients with a PriskA score between 0.2-0.8. Characteristics will include: menstrual cycle information, age, BMI, serum LH, serum FSH, serum AMH, serum testosterone, serum SHBG, serum progesterone, serum estradiol, total follicle count, PCOS phenotype (if applicable), WHO diagnosis or other endocrinological diagnosis.
Another secondary parameter is the user experience of the PriskA tool. This will be collected from every user by a questionnaire. Questionnaires will be collected from every used when he/she completed 20 patients during the study.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- PriskA tool
- 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.
PriskA toolOther
PriskA tool is an algorithm that generates a risk score of having PCOS.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Women with PCOS according to the Rotterdam criteria. Receives: Other: PriskA tool | |
| Controls | Women with PCOS. Receives: Other: PriskA tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the risk probabilities (<0.2 and >0.8) of the PriskA tool
The PriskA tool generates a risk score ranging from 0-1. Women having a risk score below 0.2 are considered having a low risk of having PCOS, women with a risk score 0.2-0.8 are considered having a moderate risk of having PCOS and women with a risk score above 0.8 have a high risk of having PCOS.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (4)
Number of patiens with a PriskA score between 0.2 and 0.8.
A secondary study parameter is to assess the number (percentage) of patients with a PriskA score between 0.2-0.8.
Measured: Through study completion, an average of 1 year.
Diagnosis of patients with a PriskA score between 0.2 and 0.8.
The official diagnosis of patients with a PriskA score between 0.2 and 0.8, including WHO I or III, or other endocrinological diagnosis.
Measured: Through study completion, an average of 1 year.
PCOS phenotype of patients with a PriskA score between 0.2 and 0.8 and PCOS diagnosis.
A secondary study parameter is to investigate the phenotype of women who receive the diagnosis PCOS but have PriskA score between 0.2 and 0.8. This will be stratified in phenotype A, B, C or D.
Measured: Through study completion, an average of 1 year.
User experience of PriskA tool
Another secondary parameter is the user experience of the PriskA tool. This will be collected from every user by a questionnaire. Questionnaires will be collected from every user when he/she completed 20 patients during the study.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Mar 2023
- Primary completion1 Sep 2023
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Principal investigator, Yvonne V Louwers, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785507
- Sponsor's protocol ID
- NL82155.078.22
- Status last verified
- Feb 2024
- First submitted
- 1 Mar 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Test the PCOS Risk Algorithm (PriskA)
- ClinicalTrials.gov ID
- NCT05785507
- Acronym / sponsor ID
- NL82155.078.22
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 27 Mar 2023 (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.
Background of the study:
With a prevalence up to 15%, polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. Women with PCOS present with diverse features, including reproductive features such as irregular menstrual cycles, subfertility, hirsutism and pregnancy complications, metabolic features such as obesity, insulin resistance, metabolic syndrome, pre-diabetes, type 2 diabetes and cardiovascular factors, and psychological features such as anxiety and depression. Because of the reproductive, metabolic and cardiovascular risk factors it is important to screen and inform these women. However, up to 70% of the affected women remain undiagnosed. In academic hospitals (tertiary care) the diagnosis PCOS will rarely be missed by gynecologists. However, in peripheral hospitals or for internal medicine physicians, PCOS and its criteria are less well known.
Therefore, the PCOS risk algorithm (PriskA), a digital tool to use in the assessment of PCOS in patients with signs and symptoms of PCOS, is developed. To exclude patients with a WHO I status, the tool exclude women with low Luteinizing Hormone (LH) and low Follicle-Stimulating Hormone (FSH) in advance. Women with LH and FSH within the normal range will be used in the algorithm for further assessment. The algorithm uses clinical data including age, BMI and information about irregular menstrual cycle in combination with anti-Mullerian hormone (AMH), testosterone and Sex Hormone Binding Globulin (SHBG) to generate a risk score ranging from 0-1. Women having a risk score below 0.2 are considered having a low risk of having PCOS, women with a risk score 0.2-0.8 are considered having a moderate risk of having PCOS and women with a risk score above 0.8 have a high risk of having PCOS.
Objective of the study:
In this study we aim to assess the validity of the PriskA algorithm to diagnose PCOS in a pilot study with patients presenting with signs and symptoms of PCOS. The study also aims to collect information on the user experience from the clinicians and to provide useful information to support the design of a validation study.
Study design:
This study will be a prospective, mono-center observational pilot study and it will be conducted at the Department of Reproductive Endocrinology at the Erasmus University Medical Center Rotterdam, the Netherlands. We estimate that the study will be completed within one year.
Study population:
Women with symptoms of PCOS who are referred to the Department of Reproductive Endocrinology at the Erasmus University Medical Center Rotterdam, and are undergoing a standardized screening (COLA screening, which stands for: (menstrual) Cycle problems, Oligomenorrhea and Amenorrhea). The COLA screening is part of standard clinical care. Women with one or more symptoms of PCOS will be included in the study. Women who eventually getting the diagnosis PCOS by standard screening will be labelled as cases and women who have one PCOS symptom and did not get the diagnosis PCOS will be labelled as controls.
Primary study parameters/outcome of the study:
The validity of the PriskA tool to diagnose PCOS, by assessing the sensitivity and specificity of the risk probabilities of 0.2 and 0.8.Parameters that will be used:
- Testosterone level in serum (using Elecsys using Cobas 6000)
- SHBG level in serum (using Elecsys using Cobas 6000).
- AMH level in serum (using Elecsys using Cobas 6000).
- LH level in serum (using Elecsys using Cobas 6000)
- FSH level in serum (using Elecsys using Cobas 6000)
- Cycle information
- Age
- BMI
Secondary study parameters/outcome of the study:
A secondary study parameter is to assess the number (percentage) and characteristics of patients with a PriskA score between 0.2-0.8. Characteristics will include: menstrual cycle information, age, BMI, serum LH, serum FSH, serum AMH, serum testosterone, serum SHBG, serum progesterone, serum estradiol, total follicle count, PCOS phenotype (if applicable), WHO diagnosis or other endocrinological diagnosis.
Another secondary parameter is the user experience of the PriskA tool. This will be collected from every user by a questionnaire. Questionnaires will be collected from every used when he/she completed 20 patients during the study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: PriskA toolWomen with PCOS according to the Rotterdam criteria. |
| Controls | – | Other: PriskA toolWomen with PCOS. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Women with symptoms of PCOS who are referred to the Department of Reproductive Endocrinology at the Erasmus University Medical Center Rotterdam, and are undergoing a standardized screening (COLA screening, which stands for: (menstrual) Cycle problems, Oligomenorrhea and Amenorrhea) will be asked to participate. The COLA screening is part of standard clinical care. Women with one or more symptoms of PCOS will be included in the study. Women who eventually getting the diagnosis PCOS by standard screening will be labelled as cases and women who have one PCOS symptom and did not get the diagnosis PCOS will be labelled as non-PCOS.
Key inclusion criteria (4 listed)
- Women with signs and symptoms of PCOS, including: irregular or absent menstrual cycle, hirsutism or polycystic ovarian morphology who undergoing a standardized screening (COLA screening)
- Age range 16-45 years
- Sufficient command of the Dutch language
- Signed written informed consent
Key exclusion criteria (5 listed)
- Documented ongoing pregnancy
- Malignancy (documented malignancy, documentation of current radiation therapy or chemotherapy in medical record)
- If transvaginal ultrasound is not possible or it is inappropriate
- Not willing to share clinical data with Roche and Evidencio
- Use of hormonal medication in the past three months, including hormonal IUD
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 |
|---|---|---|
| PriskA toolPriskA tool is an algorithm that generates a risk score of having PCOS. | Other | Cases, Controls |
Primary outcome
Sensitivity and specificity of the risk probabilities (<0.2 and >0.8) of the PriskA tool
Time frame: Through study completion, an average of 1 year.
The PriskA tool generates a risk score ranging from 0-1. Women having a risk score below 0.2 are considered having a low risk of having PCOS, women with a risk score 0.2-0.8 are considered having a moderate risk of having PCOS and women with a risk score above 0.8 have a high risk of having PCOS.
4 secondary outcomes
Number of patiens with a PriskA score between 0.2 and 0.8.
Time frame: Through study completion, an average of 1 year.
Diagnosis of patients with a PriskA score between 0.2 and 0.8.
Time frame: Through study completion, an average of 1 year.
PCOS phenotype of patients with a PriskA score between 0.2 and 0.8 and PCOS diagnosis.
Time frame: Through study completion, an average of 1 year.
User experience of PriskA tool
Time frame: Through study completion, an average of 1 year.
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 28 Feb 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Syndrome, run by Erasmus Medical Center at 1 site in Netherlands.
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 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: finished, as of the sponsor's last update on 28 Feb 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 Netherlands. 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?
Sensitivity and specificity of the risk probabilities (<0.2 and >0.8) of the PriskA tool (time frame: Through study completion, an average of 1 year.). 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 28 Feb 2024.