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Active, Not Recruiting

NCT Number: NCT06339567

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Paris Saint Joseph

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Thrombotic profile

Diagnostic Test

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Insuline resistance and weight

    Time frame: 1 year

    Estimate the prevalence of overweight, obesity, and insulin resistance in women with with PCOS

  2. comparison of procoagulant profile depending on insulin resistance

    Time frame: 1 year

    comparison of procoagulant biomarker for women with or without insulin resistance

  3. comparison of procoagulant profile depending on hyperangrogenism

    Time frame: 1 year

    comparison of procoagulant biomarker for women with or without hyperangrogenism

  4. comparison of procoagulant profile depending on PCOS phenotype

    Time frame: 1 year

    comparison of procoagulant biomarker depending on PCOS phenotype

  5. comparison of procoagulant profile depending on AMH Rate

    Time frame: 1 year

    comparison of procoagulant biomarker depending on AMH Rate

  6. comparison of QoL score depending on PCOS phenotype

    Time frame: 1 year

    comparison of PCOS-QoL, SF36 and HADS scores depending on PCOS phenotype

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Acronym: Hemo-PCOS

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Apr 1, 2024
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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