PPOS and CFA for Elective Freeze-all Ovarian Stimulation Cycles: a Prospective Cross-over Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Treatment-related quality of life and patient satisfaction after comparing two different ovulation stimulation cycles
研究概览
简要总结
P-CCROSS is a randomized, prospective monocentric phase 4 study with a crossover study design. The aim of the study is to compare patient satisfaction (by means of questionnaires) and treatment compliance with IVF treatment with CFA (corifollitropin alfa) and PPOS (Progestin-Primed Ovarian Stimulation) versus conventional IVF treatment with a recombinant FSH/GnRH antagonist. The study will also compare patients undergoing elective fertility preservation versus PGT-A (pre-implantation genetic testing for aneuploidy) patients.The study will have a crossover design so that patients will receive both forms of treatment. The investigators will also compare the endocrine profile and ovarian response of CFA/PPOS versus rFSH/GnRH ovarian stimulation cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •contra-indication for ovarian stimulation
- •expected poor ovarian response (Bologna Criteria)
- •PCOS patients
- •refusal to fill out questionnaires before, during and after treatment
- •simultaneous participation in another clinical study
- •untreated and uncontrolled thyroid dysfunction;
- •current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy;
- •pregnant or breastfeeding women. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
研究组 & 干预措施
CFA/PPOS cycle
Interventional stimulation
干预措施: Elonva® (Drug)
CFA/PPOS cycle
Interventional stimulation
干预措施: Puregon® (Drug)
CFA/PPOS cycle
Interventional stimulation
干预措施: Gonapeptyl® (Drug)
CFA/PPOS cycle
Interventional stimulation
干预措施: Cerazette® (Drug)
rFSH / GnRH antagonist cycle
Conventional stimulation
干预措施: Puregon® (Drug)
rFSH / GnRH antagonist cycle
Conventional stimulation
干预措施: Orgalutran® (Drug)
rFSH / GnRH antagonist cycle
Conventional stimulation
干预措施: Gonapeptyl® (Drug)
结局指标
主要结局
Treatment-related quality of life and patient satisfaction after comparing two different ovulation stimulation cycles
时间窗: Six months
Comparison of CFA / PPOS stimulation versus conventional rFSH / GnRH antagonist ovarian stimulation cycles with respect to mean treatment-related quality of life and patient satisfaction. Treatment-related quality of life and patient satisfaction retrieved from the second questionnaire (Q2), which is completed at the end of each stimulation cycle; after the agonist trigger and before the oocyte retrieval.Q2 is a combination of the treatment module of the validated FertiQoL questionnaire and the EFESO questionnaire. This questionnaire will assess the environment and tolerability of the fertility treatment.
次要结局
未报告次要终点