Construction of a Multi-dimensional Risk Assessment System: a Clinical Study of Polycystic Ovary Syndrome Complicated With Thrombophilia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age14-45
SponsorGuangdong Women and Children Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female participants aged 14 to 45 years

Diagnosis of polycystic ovary syndrome (PCOS)

For adult participants, PCOS diagnosed according to the 2023 international evidence-based guideline. After exclusion of related disorders, diagnosis is based on ovulatory dysfunction and/or irregular menstrual cycles together with clinical hyperandrogenism, biochemical hyperandrogenism, or polycystic ovarian morphology on ultrasound where appropriate

For adolescent participants, PCOS 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

Disqualifiers

Confirmed pregnancy

Hematologic disease

History of malignant tumor

Use of medications within 12 weeks before enrollment that may interfere with study assessments

Trial population

Female participants aged 14 to 45 years with polycystic ovary syndrome will be enrolled. Participants will be classified according to the presence or absence of decreased protein C and/or protein S levels.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: PCOS with decreased protein C and/or protein S
Group B: PCOS without decreased protein C or protein S

Trial outcomes

Primary outcomes

1

Decreased protein C and/or protein S levels

Assessment of decreased protein C and/or protein S levels in women with polycystic ovary syndrome at study enrollment based on laboratory testing.

Time frame
At baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

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