Evaluation of Pain in the Course of in Vitro Fertilization

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Pain in the Course of in Vitro Fertilization: the Endalgofiv Study

Conditions
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Infertility

Intervention / Treatment
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* Other: Using different survey to evaluate pain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who start an IVF cycle in the medically assisted procreation department of the Jeanne de Flandres Hospital (CHRU Lille) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Using different survey to evaluate pain|Survey will be at different time of the IVF protocol (at the first medical appointment in the medically assisted department, after stimulation, after oocytes retrieval, after embryo transfer, one month after the IVF protocol)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | composite criteria to assess of the typology of pain | one month after the IVF protocol | 
| EN = numerical scale of pain | from 0 to 10 (0 is no pain and 10 is maximum pain imaginable) | one month after the IVF protocol | 
| Questionnaire douleur Saint Antoine (QDSA) | 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) | one month after the IVF protocol | 
| DN4 | emotional and sensory dimension of pain, neuropathic pain survey in four questions - score on 7 | one month after the IVF protocol | 
| EQ-5D quality of life | 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) | one month after the IVF protocol | 
| HAD,anxiety and depression | 2 scores on 21 - circle the number that best fits your condition | one month after the IVF protocol | 
| pain catastrophism scale (PCS) | score between 0 to 52 | one month after the IVF protocol | 
| heiQ = personal efficiency, | 40 questions with 8 dimensions | one month after the IVF protocol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | composite criteria to assess of the typology of pain | at Baseline (the first medical appointment) and 15 days after the embryo transfer | 
| implantation rates (%) | measure in endometriotic and non-endometriotic patients,in primary and secondary infertility patients | at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle | 
| pregnancy rate (%) | measure in endometriotic and non-endometriotic patients,in primary and secondary infertility patients | 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) | measure in endometriotic and non-endometriotic patients,in primary and secondary infertility patients | 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 | measure the impact of pain on the pregnancy project in endometriotic and non-endometriotic patients,in primary and secondary infertility patients | at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle | 
| willingness to take a specific treatment with an analgesic goal: yes or no answer | measure the impact of pain on the pregnancy project in endometriotic and non-endometriotic patients,in primary and secondary infertility patients | at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infertility, In Vitro Fertilization, Endometriosis, pain evaluation