Overview
This observational case-control study aims to develop a multidimensional risk assessment model for thrombophilia-related abnormalities in females with polycystic ovary syndrome (PCOS). The study will analyze endocrine, metabolic, and genetic factors associated with decreased protein C and/or protein S levels in participants with PCOS. The results are expected to provide evidence for risk stratification and individualized management in this population.
Description
Polycystic ovary syndrome (PCOS) is a common endocrine disorder in females of reproductive age and is frequently associated with metabolic dysfunction and an increased risk of thrombosis. This study is designed as an observational case-control study to investigate multidimensional risk factors associated with thrombophilia-related abnormalities in females with PCOS.
Female participants aged 14 to 45 years will be enrolled. Adult participants will be diagnosed with PCOS according to the 2023 international evidence-based guideline. After exclusion of related disorders, diagnosis in adults is based on ovulatory dysfunction and/or irregular menstrual cycles together with clinical hyperandrogenism, biochemical hyperandrogenism, or polycystic ovarian morphology on ultrasound where appropriate. Adolescent participants will be diagnosed according to adolescent-specific recommendations. After exclusion of related disorders, both ovulatory dysfunction and/or irregular menstrual cycles and clinical or biochemical hyperandrogenism are required. Polycystic ovarian morphology alone will not be used to diagnose PCOS in adolescents.
Participants will be classified into a case group and a control group according to the presence or absence of decreased protein C and/or protein S levels. Endocrine, metabolic, and genetic variables will be collected and analyzed. Statistical analyses will include descriptive analysis, group comparisons, univariable analysis, multivariable logistic regression, and model performance evaluation using receiver operating characteristic curves and the area under the curve.
The primary outcome is decreased protein C and/or protein S levels at baseline. The goal of this study is to construct a multidimensional risk assessment model for thrombophilia-related abnormalities in females with PCOS and to provide evidence for risk stratification and individualized management.
Eligibility
Inclusion Criteria:
- age \> 40 years;
- pain duration \> 1 month;
- pain intensity ≥ 40/100 on visual analog scale;
- SPADI ≥ 30/100;
- medication against pain stable at least 30 days before enrolment;
- pain with or without weakness during the Jobe manoeuver;
- ultrasonography within the 30 days, showing tendinopathy of the supra-spinatus, with or without tear;
- affiliation to health insurance Sécurité Sociale;
- ability to give consent, complete the weekly notebook (collection of drug treatments taken against pain);
- availability for the visits planned by the protocol;
- use of an effective method of contraception in women of childbearing potential, started at least 1 month before and lasting for at least 1 month after receiving study treatment.
- Negative urine test for women of childbearing age
Exclusion Criteria:
- reduced passive range of motion;
- antero-posterior instability;
- tendinous calcification;
- ultrasonography showing concomitant tear of the infra-spinatus or the subscapularis;
- corticosteroid injection within the previous 30 days;
- previous surgery of the shoulder;
- humeral fracture, inflammatory joint disease and neoplastic disorders;
- contraindication to XEOMIN® (allergy to XEOMIN® or any other botulinum toxin product);
- skin infection at the planned injection site;
- participation in another interventional research involving the human person (RIPH) during the 3 months of follow-up of the DEROTOX Research; participation in another RIPH will be possible beyond these 3 months;
- concomitant use of aminoglycosides, cyclosporine, aminoquinolines and spectinomycine;
- patients with a history of aspiration pneumonia and dysphagia;
- patients on anticoagulant therapy or on therapy that may have an anticoagulant effect;
- Patients with bleeding disorders;
- Patients with amyotrophic lateral sclerosis, myasthenia gravis or, Lambert-Eaton syndrome;
- Patients with other conditions causing peripheral neuromuscular dysfunction;
- In target muscles that show pronounced weakness or atrophy;
- Women of childbearing age who have not performed a urine pregnancy test and or who have a positive urine pregnancy test;
- in case of pregnancy, breastfeeding
- injection of botulinum toxin in the last 6 months
- vulnerable people (under legal protection, guardianship or curatorship)
