Kineret® als neue Therapiemöglichkeit für Frauen mit Polyzystischem Ovarialsyndrom (PCOS) – Die FertIL-Studie.

Drug: IL-1 receptor antagonist Anakinra

Inclusion Criteria:

- Informed Consent as documented by signature

- Premenopausal women aged 18 years or older

- Onset of menarche =5 years ago

- Diagnosis of PCOS defined by the Rotterdam criteria

- High sensitivity C-reactive protein level =1 mg/l

- Follicular phase of menstrual cycle as evident by

- Serum estradiol level <200 pmol/l AND

- Serum progesterone level <8 ng/ml

- Willingness to use non-hormonal contraceptive measures adequate to prevent becoming
pregnant during the study

Exclusion Criteria:

- Intake of any testosterone level modifying drugs in the 8 weeks prior to study
inclusion,

- Contraindications to the class of drugs under study, e.g. known hypersensitivity or
allergy to Anakinra/Kineret,

- Women who are pregnant or breast feeding,

- Female participants who are ovariectomized or hysterectomised or post-menopausal

- Known or suspected non-compliance, drug or alcohol abuse,

- Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, dementia, etc. of the participant,

- Participation in another study with investigational drug within the 30 days preceding
and during the present study,

- Previous enrolment into the current study,

- Enrolment of the investigator, his/her family members, employees and other dependent
persons,

- Clinical signs of infection in the week before inclusion or history of a severe
infection during the last 2 months,

- Potentially severe immunosuppression or intake of other immunosuppressive drugs

- Severe hematologic disease

- Other clinically significant concomitant disease states (e.g., renal failure, hepatic
dysfunction, active carcinoma),

- History of or suspected tuberculosis and/or hepatitis B/C