Evaluation of the Venous Thrombotic Biological Profile of Different PCOS Phenotypes: French Cross-sectional Study

Polycystic Ovary Syndrome Clinical Trial

— Hemo-PCOS  

Official title:

Evaluation of the Venous Thrombotic Biological Profile of Different PCOS Phenotypes: French Cross-sectional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06339567
• Other study ID #: 671_Hemo-PCOS
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2024
• Est. completion date: February 7, 2029

Study information

• Verified date: March 2024
• Source: Fondation Hôpital Saint-Joseph
• Contact: Justine Hugon Rodin, MD
• Phone: +33144127883
• Email: jhugon[@]ghpsj.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: February 7, 2029
• Est. primary completion date: February 7, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

• 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).

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Diagnostic Test:
• Thrombotic profile
several thrombotic biological marker will be dosed in blood. (C protein, S protein, CRP us, Factor VIII, TFPI , nAPCsr, SHBG, nTMsr)

Locations

Country	Name	City	State
France	Hôpital Paris Saint Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Hôpital Saint-Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one year
Secondary	Insuline resistance and weight	Estimate the prevalence of overweight, obesity, and insulin resistance in women with with PCOS	1 year
Secondary	comparison of procoagulant profile depending on insulin resistance	comparison of procoagulant biomarker for women with or without insulin resistance	1 year
Secondary	comparison of procoagulant profile depending on hyperangrogenism	comparison of procoagulant biomarker for women with or without hyperangrogenism	1 year
Secondary	comparison of procoagulant profile depending on PCOS phenotype	comparison of procoagulant biomarker depending on PCOS phenotype	1 year
Secondary	comparison of procoagulant profile depending on AMH Rate	comparison of procoagulant biomarker depending on AMH Rate	1 year
Secondary	comparison of QoL score depending on PCOS phenotype	comparison of PCOS-QoL, SF36 and HADS scores depending on PCOS phenotype	1 year