Evaluation of Pain in the Course of in Vitro Fertilization: the Endalgofiv-2 Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Questionnaire douleur Saint Antoine (QDSA)
研究概览
简要总结
The ENDALGOFIV study of pain assessment during the IVF pathway at Lille University Hospital, conducted from November 2018 to July 2020, showed that endometriosis patients have intense pain, particularly of a neuropathic nature, even before starting their IVF pathway compared to patients without endometriosis, but without an increase in pain scores during the IVF pathway. As a result of this study, a new pain management protocol for all patients undergoing IVF have been implemented in our MPA center. The study will be evaluated the impact of this new management.
Main objective To evaluate the effect of the change in pain management protocol in all patients (endometriotic or not) undergoing IVF treatment during the study period by comparing them to the data of the ENDALGOFIV 1 study.
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 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients who start an IVF cycle in the medically assisted procreation department of the Jeanne de Flandres Hospital (CHRU Lille)
排除标准
- •Previously enrolled patient (ENDALGOFIV or ENDALGOFIV 2)
- •Refusal to participate in the study
- •Minor patient
- •Patient over 43 years old
- •BMI patient > 35
- •Pregnant woman
- •Unable to provide clear information to the patient
- •Patient under guardianship or lack of health cover
- •Patient in IVF with donation of oocyte
- •IVF patients for oocyte preservation
- •Patient who had already participated in the study
结局指标
主要结局
Questionnaire douleur Saint Antoine (QDSA)
时间窗: After puncture, before discharge from hospital (assessed up to 24 hours)
QDSA for emotional and sensory dimension of pain. It's a word list to describe a pain, patient must specify the type of pain that she usually feels for 8 days by putting a cross for the correct answer (0 to 4: absent, weak, moderate, strong, extremely strong). Scored from 0 to 64
次要结局
- HAD,anxiety and depression(At baseline and during procedure ( an average up to 6 weeks))
- pain catastrophism scale (PCS)(At baseline and during procedure ( an average up to 6 weeks))
- Questionnaire douleur Saint Antoine (QDSA)(At baseline and during procedure ( an average up to 6 weeks))
- DN4(At baseline and during procedure ( an average up to 6 weeks))
- willingness to go the pain consultation: yes or no answer(during the stimulation period (an average 10 days))
- EN = numerical scale of pain(At baseline and during procedure ( an average up to 6 weeks))
- EQ-5D quality of life(At baseline and during procedure ( an average up to 6 weeks))
- willingness to take a antalgic medication during the stimulation: yes or no answer(during the stimulation period (an average 10 days))
- willingness to take a antalgic medication during the punction: yes or no answer(during the stimulation period (an average 10 days))