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临床试验/NCT02302781
NCT02302781已完成不适用

Why Subfertile Couples Drop Out (Drop Out Trial); a Prospective Survey in the Netherlands.

Isala7 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Isala
入组人数
500
试验地点
7
主要终点
Dropout rates

研究概览

简要总结

Dropout rates for fertility treatments are high. This study will examine the rate of patients that drop out during any type of subfertility work up or treatment. Furthermore, we will determine what reasons for discontinuation are and we will identify the demographic characteristics of the couples and the prognostic factors for drop out during assessment or treatment at a Fertility Centre in the Isala (Zwolle), Erasmus University Centre (Rotterdam), Elisabeth Twee Steden Hospital (Tilburg), Reinier de Graaf Group (Voorburg), St Antonius Hospital (Nieuwegein), Maxima Medical Centre (Veldhoven) and Noordwest Hospital Group (Den Helder/Alkmaar) in The Netherlands.

详细描述

Rationale Although fertility success rates are rising due to improved techniques and patients are usually highly motivated at their first visit of the clinic, dropout rates are high. Research has shown that fertility treatment is a cause for physical, psychological and economic burden.

Objective The aim of this study is to examine the rate of patient drop out during any type of subfertility work up or treatment. Furthermore, the investigators want to determine what the reasons for discontinuation are and to identify the demographic characteristics of these couples and the prognostic factors for drop out during assessment or treatment at a fertility clinic.

Study design Prospective cohort study at the fertility centres of Isala (Zwolle - The Netherlands), Erasmus University Centre (Rotterdam- The Netherlands), Elisabeth Twee Steden Hospital (Tilburg - The Netherlands), Reinier de Graaf Group (Voorburg - The Netherlands), St Antonius Hospital (Nieuwegein - The Netherlands), Maxima Medical Centre (Veldhoven - The Netherlands) and Noordwest Hospital Group (Den Helder/Alkmaar - The Netherlands).

Study population Every couple that undergoes any type of work up or treatment for subfertility problems and that has not visited any other clinic yet.

Methods Patient records of included couples will be studied and included patients will be asked to fill in a validated questionnaire after evaluations during work up or treatment. The data from both will be put in a database and analysed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Couples with any type of subfertility referred to one of the four participating centres
  • Both partners are willing and able to separately fill out the questionnaires.

排除标准

  • Unable to read or speak the Dutch language
  • Medical contra-indication for pregnancy
  • Previous OFO (initial infertility consultation), non IVF or IVF/ICSI cycles

结局指标

主要结局

Dropout rates

时间窗: 5 years

To identify dropout rates at all stages of fertility care at the fertility centres of Isala (Zwolle), Erasmus MC (Rotterdam), IVF centre Voorburg (Voorburg), st Elisabeth (Tilburg).

次要结局

  • Demographic characteristics(5 years)
  • Predictors(5 years)
  • Reasons(5 years)
  • Patient satisfaction(5 years)

研究者

发起方
Isala
申办方类型
Other
责任方
Principal Investigator
主要研究者

B.J. Cohlen

Dr. B.J. Cohlen, Fertility Centre Isala

Isala

研究点 (7)

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