2024-519354-36-00招募中4 期
Continuing ovulation induction with letrozole versus switching to gonadotropins in women with polycystic ovary syndrome
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 816
- 试验地点
- 26
- 主要终点
- Pregnancy within 8 months after randomization, leading to a live birth
研究概览
简要总结
To determine the clinical efficacy of continuing ovulation induction with letrozole versus switching to ovarian stimulation with gonadotropins, in terms of cumulative live birth rate improvement
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Couples or single women with childwish
- •Diagnosed PCOS (normogonadotropic anovulation with hyperandrogenaemia (diagnosed clinically by the presence of excessive acne, androgenic alopecia, or hirsutism or by elevated serum levels of total, bioavailable, or free testosterone or dehydroepiandrosterone sulfate) or polycystic ovaries on ultrasound)
- •Age 18-43 years
- •Ovulatory for six cycles on letrozole treatment
排除标准
- •Contra-indication to letrozole
- •Partner with abnormal semen analysis according the WHO guidelines
- •Known to have no patency of at least one Fallopian tube
- •Major medical morbidity (e.g. poorly controlled Type I or Type II diabetes, known liver disease or dysfunction based on serum liver enzyme testing, renal disease or abnormal serum renal function)
- •Inability to give informed consent
- •Additional contra-indications reported in the SPC are: Hypersensitivity to the active substance, during pregnancy and breast feeding
结局指标
主要结局
Pregnancy within 8 months after randomization, leading to a live birth
Pregnancy within 8 months after randomization, leading to a live birth
次要结局
- 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
研究者
Dr. M. van Wely
Scientific
Amsterdam UMC Stichting
研究点 (26)
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