Polycystic Ovary Syndrome (PCOS)SOPKNCT07339930
Phenotyping of Patients With Polycystic Ovary Syndrome
An observational study of Polycystic Ovary Syndrome (PCOS), run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Polycystic ovary syndrome (PCOS) is the leading endocrine disorder of the reproductive system, affecting 10 to 13% of women of childbearing age. However, there is a significant delay in diagnosis, which may be due to considerable clinical heterogeneity and a lack of information among the general population. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS)
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2025to 17 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 49 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adult woman (≥18 years and <50 years) who consulted at the Strasbourg University Hospitals for suspected PCOS or for any other endocrinological condition that led to the discovery of PCOS.
Who may be able to join
- Adult woman (≥18 years and <50 years)
- Subject who consulted at the Strasbourg University Hospitals for suspected PCOS or for any other endocrinological condition that led to the discovery of PCOS.
Who cannot join
- Final diagnosis excluding PCOS.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
ervice d'Endocrinologie, Diabétologie et Nutrition - CHU de Strasbourg - France
Strasbourg, 67091
Thibault BAHOUGNE, MD, 33 3.88.12.78.99, thibault.bahougne@chru-strasbourg.fr
Thibault BAHOUGNE, MD
About this study
Official title: Phenotyping of Patients With Polycystic Ovary Syndrome (PCOS) in Alsace, France
Polycystic ovary syndrome (PCOS) is the leading endocrine disorder of the reproductive system, affecting 10 to 13% of women of childbearing age. However, there is a significant delay in diagnosis, which may be due to considerable clinical heterogeneity and a lack of information among the general population. The diagnosis is made when two of the three Rotterdam criteria established in 2003 and revised in 2023 are met, namely: 1) menstrual cycle disorders (oligoanovulation) - 2) clinical or biological hyperandrogenism - 3) OPK morphological appearance or elevated anti-Müllerian hormone (AMH) levels, after exclusion of differential diagnoses. PCOS is a condition that carries a risk of metabolic complications and fertility problems due to dysovulation. Patients have an impaired quality of life and are at greater risk of anxiety and depression, which should be screened for systematically.
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Keywords
- Polycystic ovary syndrome (PCOS), Polycystic Ovary, Endocrine disorder, Menstrual cycle disorders, Anti-Müllerian hormone (AMH)
- Medical subject headings
- Polycystic Ovary Syndrome, Endocrine System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of obesity
The prevalence of obesity indicates the proportion of obese individuals in a population (a country, a region, a school, etc.) at a given time.
It is often expressed as a percentage.
Example:
If, in a region of 1,000 inhabitants, 200 people are obese,
→ the prevalence of obesity is 20%.
Measured: Up to 12 months
Biological Indicators of Insulin Resistance
Biological Indicators of Insulin Resistance:
- Fasting Blood Glucose (Blood Sugar) Measured after 8-12 hours of fasting. Normal: ~0.70 to 1.00 g/L (3.9-5.6 mmol/L) Abnormal: ≥1.00 g/L may suggest a disorder
- Fasting Insulin Indicates how much insulin the body produces at rest. Normal (approx.): 2 to 10 µIU/mL High: > 10-12 µIU/mL → suspected insulin resistance
- HOMA-IR Index (most commonly used)
Calculated with:
fasting blood glucose × fasting insulin ÷ 22.5 (in mmol/L)
Common interpretation:
< 2: normal insulin sensitivity 2-2.9: possible insulin resistance
≥ 3: probable insulin resistance
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start17 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completion17 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339930
- Sponsor's protocol ID
- 9772
- Acronym
- SOPK
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotyping of Patients With Polycystic Ovary Syndrome (PCOS) in Alsace, France
- ClinicalTrials.gov ID
- NCT07339930
- Acronym / sponsor ID
- SOPK / 9772
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Keywords
- Polycystic ovary syndrome (PCOS), Polycystic Ovary, Endocrine disorder, Menstrual cycle disorders, Anti-Müllerian hormone (AMH)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- 17 Sep 2026 (estimated)
- First posted
- 14 Jan 2026 (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 (PCOS) is the leading endocrine disorder of the reproductive system, affecting 10 to 13% of women of childbearing age. However, there is a significant delay in diagnosis, which may be due to considerable clinical heterogeneity and a lack of information among the general population. The diagnosis is made when two of the three Rotterdam criteria established in 2003 and revised in 2023 are met, namely: 1) menstrual cycle disorders (oligoanovulation) - 2) clinical or biological hyperandrogenism - 3) OPK morphological appearance or elevated anti-Müllerian hormone (AMH) levels, after exclusion of differential diagnoses. PCOS is a condition that carries a risk of metabolic complications and fertility problems due to dysovulation. Patients have an impaired quality of life and are at greater risk of anxiety and depression, which should be screened for systematically.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult woman (≥18 years and <50 years) who consulted at the Strasbourg University Hospitals for suspected PCOS or for any other endocrinological condition that led to the discovery of PCOS.
Key inclusion criteria (2 listed)
- Adult woman (≥18 years and <50 years)
- Subject who consulted at the Strasbourg University Hospitals for suspected PCOS or for any other endocrinological condition that led to the discovery of PCOS.
Key exclusion criteria (1 listed)
- Final diagnosis excluding PCOS.
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
Prevalence of obesity
Time frame: Up to 12 months
The prevalence of obesity indicates the proportion of obese individuals in a population (a country, a region, a school, etc.) at a given time. It is often expressed as a percentage. Example: If, in a region of 1,000 inhabitants, 200 people are obese, → the prevalence of obesity is 20%.
Biological Indicators of Insulin Resistance
Time frame: Up to 12 months
Biological Indicators of Insulin Resistance: 1. Fasting Blood Glucose (Blood Sugar) Measured after 8-12 hours of fasting. Normal: ~0.70 to 1.00 g/L (3.9-5.6 mmol/L) Abnormal: ≥1.00 g/L may suggest a disorder 2. Fasting Insulin Indicates how much insulin the body produces at rest. Normal (approx.): 2 to 10 µIU/mL High: > 10-12 µIU/mL → suspected insulin resistance 3. HOMA-IR Index (most commonly used) Calculated with: fasting blood glucose × fasting insulin ÷ 22.5 (in mmol/L) Common interpretation: < 2: normal insulin sensitivity 2-2.9: possible insulin resistance ≥ 3: probable insulin resistance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
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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.
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 (PCOS), run by University Hospital, Strasbourg, France at 1 site in France.
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: looking for participants now, as of the sponsor's last update on 14 Jan 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thibault BAHOUGNE, MD (33 3.88.12.78.99, thibault.bahougne@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of obesity (time frame: Up to 12 months). 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 14 Jan 2026.