Polycystic Ovary SyndromeHemo-PCOSNCT06339567
Evaluation of the Venous Thrombotic Biological Profile of Different PCOS Phenotypes: French Cross-sectional Study
A study testing Thrombotic profile in people with Polycystic Ovary Syndrome, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of women of childbearing age. PCOS can be individualized into several phenotypes, taking into account in particular the presence of hyperandrogenism, insulin resistance and BMI. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Thrombotic profile
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2024to 7 Feb 2027
- Phase
- Interventional
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Be between 18 and 35 years of age at the time of inclusion;
- Able to give non-opposition
- Strong suspicion of PCOS according to 2023 recommendations
- Have stopped hormonal contraception for at least 3 months or insulin-sensitizing treatment for at least 3 months.
- Fasting for at least 12 hours.
- Be affiliated to a health insurance scheme.
- French-speaking
Who cannot join
- Already included in a type 1 interventional research protocol (RIPH1).
- Be under guardianship or curatorship
- Deprived of liberty
- Under court protection
- Pregnant (positive urine or blood pregnancy test), or within 3 months of post-partum or post abortum, or breastfeeding (or within 3 months of weaning)
- Using hormonal contraception or insulin-sensitizing therapy (a wash-out of at least 3 months before inclusion).
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- Have a personal history of VTE or known thrombophilia.
- Current anticoagulant or antiaggregant treatment or treatment stopped less than one month before inclusion.
- Have a severe personal medical history in the previous 6 weeks (fracture, infection, hospitalization, surgery, cardiovascular event, cancer).
Trial locations and contacts
1 site in 1 country.
About this study
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of women of childbearing age. PCOS can be individualized into several phenotypes, taking into account in particular the presence of hyperandrogenism, insulin resistance and BMI. Hyperandrogenism and insulin resistance appear to be important factors in the development of cardiovascular cardiovascular disease. In addition, patients frequently use anti-androgenic and/or contraceptive treatments contraceptives, such as combined hormonal contraception (CHC), the use of which is associated with an increased cardiovascular and thrombo and venous thrombosis (VTE). A meta-analysis published in 2020 by Gariani et al.
based on three large studies, estimated the risk of VTE in women with PCOS after adjustment for obesity and hormone therapy. This risk was significantly higher compared with women without PCOS (pooled OR 1.89, CI95% 1.60-2.24). No study has looked specifically investigated the risk of VTE according to different PCOS phenotypes. Such data would be very useful in clinical practice, as it would enable monitoring, contraceptive treatment and anti-androgenic anti-androgen treatment according to the PCOS phenotype, while limiting risks. Assessing the differences PCOS phenotypes is limited by the large sample size required. required. VTE is a rare event in women of childbearing age, and the number of PCOS phenotypes is high.
PCOS phenotypes. Intermediate markers of VTE risk are used in these situations. These markers are thrombin generation tests (notably ETP) and their sensitivity to activated protein C (nAPCsr) and thrombomodulin (nTMsr), as well as sex-hormone binding globulin (SHBG).
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Thrombotic profile
- 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.
Thrombotic profileDiagnostic test
several thrombotic biological marker will be dosed in blood. (C protein, S protein, CRP us, Factor VIII, TFPI , nAPCsr, SHBG, nTMsr)
| Study group | Role | What they receive |
|---|---|---|
| Thrombotic profil | Other | Not described Receives: Diagnostic Test: Thrombotic profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
biological procoagulant profile
Evaluation of the biological procoagulant profile in women of childbearing age with PCOS, in relation to the presence or absence of insulin resistance, by comparing FTE levels between women with PCOS and women without PCOS. the presence or absence of insulin resistance, by comparing ETP levels between women with PCOS without and with insulin resistance
Measured: one year
Secondary outcomes (6)
Insuline resistance and weight
Estimate the prevalence of overweight, obesity, and insulin resistance in women with with PCOS
Measured: 1 year
comparison of procoagulant profile depending on insulin resistance
comparison of procoagulant biomarker for women with or without insulin resistance
Measured: 1 year
comparison of procoagulant profile depending on hyperangrogenism
comparison of procoagulant biomarker for women with or without hyperangrogenism
Measured: 1 year
comparison of procoagulant profile depending on PCOS phenotype
comparison of procoagulant biomarker depending on PCOS phenotype
Measured: 1 year
comparison of procoagulant profile depending on AMH Rate
comparison of procoagulant biomarker depending on AMH Rate
Measured: 1 year
comparison of QoL score depending on PCOS phenotype
comparison of PCOS-QoL, SF36 and HADS scores depending on PCOS phenotype
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start8 Feb 2024
- Primary completion7 Jan 2026
- Study completion7 Feb 2027 (estimated)
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.
- 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
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339567
- Sponsor's protocol ID
- 671_Hemo-PCOS
- Acronym
- Hemo-PCOS
- Status last verified
- Aug 2026
- First submitted
- 25 Mar 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Venous Thrombotic Biological Profile of Different PCOS Phenotypes: French Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06339567
- Acronym / sponsor ID
- Hemo-PCOS / 671_Hemo-PCOS
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 7 Jan 2026 (actual)
- Study completion
- 7 Feb 2027 (estimated)
- First posted
- 1 Apr 2024 (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 most common endocrine disorder of women of childbearing age. PCOS can be individualized into several phenotypes, taking into account in particular the presence of hyperandrogenism, insulin resistance and BMI. Hyperandrogenism and insulin resistance appear to be important factors in the development of cardiovascular cardiovascular disease. In addition, patients frequently use anti-androgenic and/or contraceptive treatments contraceptives, such as combined hormonal contraception (CHC), the use of which is associated with an increased cardiovascular and thrombo and venous thrombosis (VTE). A meta-analysis published in 2020 by Gariani et al.
based on three large studies, estimated the risk of VTE in women with PCOS after adjustment for obesity and hormone therapy. This risk was significantly higher compared with women without PCOS (pooled OR 1.89, CI95% 1.60-2.24). No study has looked specifically investigated the risk of VTE according to different PCOS phenotypes. Such data would be very useful in clinical practice, as it would enable monitoring, contraceptive treatment and anti-androgenic anti-androgen treatment according to the PCOS phenotype, while limiting risks. Assessing the differences PCOS phenotypes is limited by the large sample size required. required. VTE is a rare event in women of childbearing age, and the number of PCOS phenotypes is high.
PCOS phenotypes. Intermediate markers of VTE risk are used in these situations. These markers are thrombin generation tests (notably ETP) and their sensitivity to activated protein C (nAPCsr) and thrombomodulin (nTMsr), as well as sex-hormone binding globulin (SHBG).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thrombotic profil | Other | Diagnostic Test: Thrombotic profile |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Be between 18 and 35 years of age at the time of inclusion;
- Able to give non-opposition
- Strong suspicion of PCOS according to 2023 recommendations
- Have stopped hormonal contraception for at least 3 months or insulin-sensitizing treatment for at least 3 months.
- Fasting for at least 12 hours.
Key exclusion criteria (9 listed)
- Already included in a type 1 interventional research protocol (RIPH1).
- Be under guardianship or curatorship
- Deprived of liberty
- Under court protection
- Pregnant (positive urine or blood pregnancy test), or within 3 months of post-partum or post abortum, or breastfeeding (or within 3 months of weaning)
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 |
|---|---|---|
| Thrombotic profileseveral thrombotic biological marker will be dosed in blood. (C protein, S protein, CRP us, Factor VIII, TFPI , nAPCsr, SHBG, nTMsr) | Diagnostic test | Thrombotic profil |
Primary outcome
biological procoagulant profile
Time frame: one year
Evaluation of the biological procoagulant profile in women of childbearing age with PCOS, in relation to the presence or absence of insulin resistance, by comparing FTE levels between women with PCOS and women without PCOS. the presence or absence of insulin resistance, by comparing ETP levels between women with PCOS without and with insulin resistance
6 secondary outcomes
Insuline resistance and weight
Time frame: 1 year
comparison of procoagulant profile depending on insulin resistance
Time frame: 1 year
comparison of procoagulant profile depending on hyperangrogenism
Time frame: 1 year
comparison of procoagulant profile depending on PCOS phenotype
Time frame: 1 year
comparison of procoagulant profile depending on AMH Rate
Time frame: 1 year
comparison of QoL score depending on PCOS phenotype
Time frame: 1 year
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 18 Aug 2026.
- 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?
A study testing Thrombotic profile in people with Polycystic Ovary Syndrome, run by Fondation Hôpital Saint-Joseph 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 7 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 18 Aug 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?
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?
biological procoagulant profile (time frame: one 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 18 Aug 2026.