Continuing ovulation induction with letrozole versus switching to gonadotropins in women with polycystic ovary syndrome

Polycystic ovary syndrome (PCOS)

Pregnancy within 8 months after randomization, leading to a live birth

Clinical pregnancy, ongoing pregnancy, biochemical pregnancy loss and miscarriage rates within 8 months after randomisation, For each participant, the number of treatment cycles initiated, completed and cancelled are evaluated within 8 months after randomisation, Of all achieved (ongoing) pregnancies occurring within 8 months after randomization (including spontaneous pregnancies) the following outcomes are assessed; multiple pregnancy rate, time to pregnancy, pregnancy complications, perinatal outcomes, type of delivery and outcomes, Side effects and compliance to therapy assessed during treatment using a medication dairy and a questionnaire, sent out at 3 months and 8 months after randomization, Quality of life and mental health assessed at time of randomization, and at 3 months and 6 months after randomization, using the FertiQoL questionnaire and the HADS questionnaire, Progression to IVF/ICSI within 8 months after randomization, Budget impact, Cost-effectiveness analyses using live birth rates, costs and quality of life

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Netherlands