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

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 Overview

• Status: Recruiting
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Diagnostic test: Thrombotic profile

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Justine Hugon Rodin, MD; Phone Number: +33144127883; Email: jhugon@ghpsj.fr
• Study Contact Backup: Name: Hélène Beaussier, pharmaD; Email: hbeaussier@ghpsj.fr

Study Locations

• France
  • Paris, France
    • Recruiting
    • Hopital Paris Saint Joseph
    • Contact: Hélène Beaussier, pharmaD; Email: hbeaussier@ghpsj.fr
    • Contact: Juliette COURTIADE MAHLER; Email: jcourtiade@ghpsj.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Thrombotic profil	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondation Hôpital Saint-Joseph

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2024
• Primary Completion (Estimated): February 7, 2026
• Study Completion (Estimated): February 7, 2029

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome
• Other Study ID Numbers: 671_Hemo-PCOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No