Evaluation of Pain in the Course of in Vitro Fertilization: the Endalgofiv Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 318
- 试验地点
- 1
- 主要终点
- EQ-5D quality of life
研究概览
简要总结
25 to 50% of endometriotic patients are infertile and use medically assisted procreation. In general, the assessment of pain in medically assisted procreation is very little studied. Pain assessment studies in endometriotic patients remain limited to a quantitative assessment of pain symptomatology, without contextualization of painful manifestations. The primary objective of our study is the qualitative and contextualized assessment of pain during In Vitro Fertilization (IVF) protocol in endometriotic and non-endometriotic patients. The secondary objectives of our study are the quantitative study of pain, the measurement of the impact of personal efficiency on painful symptomatology, evaluation of depression, the results of IVF (implantation, pregnancy and live birth rates), and compare pain between endometriotic or non-endometriotic patients and between primary infertility and secondary infertility. According to the results obtained in this study, therapeutic strategies for the management of pain could be proposed, with the aim of improving the quality of life and the results of IVF in these patients.
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
- •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
EQ-5D quality of life
时间窗: one month after the IVF protocol
overall score on a numeric scale "check the box that best describes your health today", 5 themes (mobility, autonomy of the person, common activities, pain / discomfort, anxiety / depression)
pain catastrophism scale (PCS)
时间窗: one month after the IVF protocol
score between 0 to 52
Comparison of the scores obtained by the pain survey (EN, QDSA, DN4), quality of life survey (EQ-5D), depression and anxiety (HAD), pain catastrophism score (PCS) and assessment of personal efficacy (heiQ).
时间窗: one month after the IVF protocol
composite criteria to assess of the typology of pain
EN = numerical scale of pain
时间窗: one month after the IVF protocol
from 0 to 10 (0 is "no pain" and 10 is "maximum pain imaginable")
HAD,anxiety and depression
时间窗: one month after the IVF protocol
2 scores on 21 - "circle the number that best fits your condition"
heiQ = personal efficiency,
时间窗: one month after the IVF protocol
40 questions with 8 dimensions
DN4
时间窗: one month after the IVF protocol
emotional and sensory dimension of pain, neuropathic pain survey in four questions - score on 7
Questionnaire douleur Saint Antoine (QDSA)
时间窗: one month after the IVF protocol
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)
次要结局
- Comparison of the scores obtained by the pain survey (EN, QDSA, DN4), quality of life survey (EQ-5D), depression and anxiety (HAD), pain catastrophism score (PCS) and assessment of personal efficacy (heiQ).(at Baseline (the first medical appointment) and 15 days after the embryo transfer)
- willingness to take a specific treatment with an analgesic goal: yes or no answer(at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle)
- live birth rate (0 or 1)(at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle)
- pregnancy rate (%)(at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle)
- implantation rates (%)(at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle)
- renouncing a new IVF attempt: yes or no(at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle)