Working IVF Patients' Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Evaluate the evolution of the quality of life of active patients during their IVF course.
研究概览
简要总结
Infertility affects approximately 1 in 6 couples and may require the use of Medically Assisted Reproduction techniques. In France, there were more than 60,000 in vitro fertilization (IVF) attempts in 2016. The burden of the IVF process is even more significant for working women, causing significant absenteeism due to medical appointments but also to the psychological discomfort caused by the management. Unfortunately, there are no studies that specifically address the quality of life of working women undergoing IVF.
The cohort project aims to measure quality of life using validated questionnaires (FertiQoL, STAI Anxiety Scale and BDI Depression Inventory) in active patients who are scheduled for a first IVF attempt. Quality of life will be measured before starting treatment and at embryo transfer and will be followed up at each embryo transfer for a maximum period of 18 months. The follow-up will end after the live birth of a child or at the end of the 18 months of follow-up.
The investigators will also evaluate, by means of a specific questionnaire, the satisfaction with the interactions between professional and private life (management and consequences of absenteeism at work, consequences on professional evolution, anxious repercussions in the professional and private domains) in the active women undergoing IVF treatment.
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 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Professionally active women aged 18 to 42 years
- •Beginning in vitro fertilization treatment at the Montpellier University Hospital
排除标准
- •Women who have already had an IVF attempt in the process of egg donation or pre-implantation diagnosis
- •History of psychotic or dissociative disorder
- •Not fluent in French
- •Not affiliated to a social security system
- •Protected by law or under curators/guardianship
- •No record of non-objection to participate in the study
结局指标
主要结局
Evaluate the evolution of the quality of life of active patients during their IVF course.
时间窗: At baseline and through study completion, at 6 months or 12 months or 18 months
Assessed by the Fertility Quality Of Life (FertiQoL) questionnaire score at 18 months or end of follow-up, compared with the one obtained at inclusion. The score obtained from this questionnaire is not based on a scale. 2 first items measures physical health and satisfaction with the quality of life in terms of fertility. 24 other items assesses the impact of fertility problems in several domains: 6 in the emotional, 6 in mind-body, 6 in the relational, 6 in social. http://sites.cardiff.ac.uk/fertiqol/description/instrument-description/
次要结局
- Look for predictive factors of dropout.(At baseline and through study completion, at 6 months or 12 months or 18 months)
- Assess work/life interactions and their relationship to quality of life.(At baseline and through study completion, at 6 months or 12 months or 18 months)
- Look for predictive factors of impaired quality of life.(At baseline and through study completion, at 6 months or 12 months or 18 months)
- To compare the characteristics of patients who achieve pregnancy versus those who fail (Quality of life, anxiety, depression...)(At baseline and through study completion, at 6 months or 12 months or 18 months)