The Evaluation of a Preparatory Information Movie on Oocyte Aspiration: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- Women's state anxiety
研究概览
简要总结
The Preparatory information on Oocyte Aspiration Movie Randomized Controlled Trial (POAM-RCT) primarily aims to evaluate whether a new preparatory information on oocyte aspiration movie (POAM) decreases the anxiety of women on the day of their first oocyte aspiration for in vitro fertilisation (IVF). The control group of this RCT will receive care as usual. The intervention group will additional be given access to a preparatory information movie on oocyte aspiration 1-3 days before their oocyte aspiration via a secured link. Women's anxiety will be assessed with the 'State module of the State Trait Anxiety Inventory (STAI-state)' upon arrival at the fertility clinic on the day of the oocyte aspiration. At the same time other questionnaires will be administered. More specifically, men's anxiety and both partner's infertility specific distress will be assessed. In addition, to these secondary outcomes, clinical pregnancy with fetal heart beat and miscarriage will be followed-up 12 weeks after the oocyte aspiration. Finally, treatment delay and treatment discontinuation and long-term clinical outcomes (i.e. live birth from the first fresh embryo transfer, clinical pregnancy with fetal heart beat from the frozen embryo transfers of 1st IVF-cycle and the 12-months cumulative clinical pregnancy rates) will be followed-up twelve months after oocyte aspiration. This RCT will include 190 women (and their male partners) treated with a 1st cycle of IVF (with or without ICSI and PGD). Analysis will be according to intention to treat.
详细描述
Title: The evaluation of a preparatory information movie on oocyte aspiration: a Randomized Controlled Trial (POAM-RCT) Study purpose: To evaluate whether the preparatory information movie on oocyte aspiration (POAM) decreases the anxiety of ART-couples on the day of their first oocyte aspiration.
Primary outcome: The primary outcome is women's 'state anxiety', which will be assessed with the reliable 'State Trait Anxiety Inventory, state module (STAI-state)' questionnaire upon arrival at the fertility clinic on the day of the oocyte aspiration.
Secondary outcomes: Three secondary patient-reported outcomes will be assessed simultaneously with the primary outcome, upon arrival at the fertility clinic for oocyte aspiration.
First, men's state anxiety will assessed with the STAI-state questionnaire. Second and third, in both women and men, infertility-specific distress will be assessed.
The following two secondary clinical outcomes will be followed-up in all couples 12 weeks after the oocyte aspiration: clinical pregnancy with fetal heart beat and miscarriage in case of clinical pregnancy with fetal heart beat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(i) Heterosexual woman and her partner
- •(ii) Dutch speaking
- •(iii) Treated with a 1st cycle of IVF (IVF or ICSI; with or without PGD)
排除标准
- •(i) Having already experienced an IVF-cycle in the same of another clinic
结局指标
主要结局
Women's state anxiety
时间窗: Responses on one single assessment of state-anxiety on the day of the oocyte aspiration (1-3 days after the intervention or control condition) will be compared between intervention and control group. No pre-intervention assessment, no change scores.
Women's anxiety will be assessed with the 'State Trait Anxiety Inventory, state module (STAI-state; score 20-80, the higher the more anxious)' questionnaire (Spielberger et al, 2015; www.mingarden.com).
次要结局
- Men's state anxiety(Responses on one single assessment of state-anxiety on the day of the oocyte aspiration (1-3 days after the intervention or control condition) will be compared between intervention and control group. No pre-intervention assessment, no change scores.)
- Women's infertility specific distress(Responses on one single assessment of distress on the day of the oocyte aspiration (1-3 days after the intervention or control condition) will be compared between intervention and control group. No pre-intervention assessment, no change scores.)
- Clinical pregnancy with fetal heart beat from the frozen embryo transfers of 1st IVF-cycle(A long duration after intervention or control condition: One year after oocyte aspiration)
- Men's infertility specific stress(Responses on one single assessment of distress on the day of the oocyte aspiration (1-3 days after the intervention or control condition) will be compared between intervention and control group. No pre-intervention assessment, no change scores.)
- Clinical pregnancy with fetal heart beat(A medium duration after intervention or control condition: 12 weeks after oocyte aspiration)
- Live birth from the first fresh embryo transfer(A long duration after intervention or control condition: One year after oocyte aspiration)
- 12-months cumulative clinical pregnancy with fetal heart beat(A long duration after intervention or control condition: One year after oocyte aspiration)
- IVF-discontinuation(A long duration after intervention or control condition: One year after oocyte aspiration)
- Miscarriage after clinical pregnancy with fetal heart beat(A medium duration after intervention or control condition: 12 weeks after oocyte aspiration)
- IVF-delay or number of untreated cycles within 12 months(A long duration after intervention or control condition: One year after oocyte aspiration)