Evaluation of Pain in the Course of in Vitro Fertilization: the Endalgofiv-2 Study

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Evaluation of Pain in the Course of in Vitro Fertilization: the Endalgofiv-2 Study

Conditions
-----------------
Infertility

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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: 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

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

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). Scored from 0 to 64 | After puncture, before discharge from hospital (assessed up to 24 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire douleur Saint Antoine (QDSA) | compare the evolution of pain during study between the 2 groups endometriosis - non endometriosis | At baseline and during procedure ( an average up to 6 weeks) | 
| EN = numerical scale of pain | from 0 to 10 (0 is no pain and 10 is maximum pain imaginable) compare the evolution of pain during study between the 2 groups endometriosis - non endometriosis | At baseline and during procedure ( an average up to 6 weeks) | 
| DN4 | emotional and sensory dimension of pain, neuropathic pain survey in four questions - score on 7 compare the evolution of pain during study between the 2 groups endometriosis - non endometriosis | At baseline and during procedure ( an average up to 6 weeks) | 
| HAD,anxiety and depression | 2 scores on 21 - circle the number that best fits your condition Compare the evolution of pain during study according to the 2 periods (ENDALGOFIV 1 patients and patients who benefited from the new management protocol) | At baseline and during procedure ( an average up to 6 weeks) | 
| 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) Compare the evolution of pain during study according to the 2 periods (ENDALGOFIV 1 patients and patients who benefited from the new management protocol) | At baseline and during procedure ( an average up to 6 weeks) | 
| pain catastrophism scale (PCS) | score between 0 to 52. Compare the evolution of pain during study according to the 2 periods (ENDALGOFIV 1 patients and patients who benefited from the new management protocol) | At baseline and during procedure ( an average up to 6 weeks) | 
| willingness to go the pain consultation: yes or no answer | measure the impact of the pain on the pregnancy project and on the analgesic management after stimulation between the 2 endometriosis - non-endometriosis groups | during the stimulation period (an average 10 days) | 
| willingness to take a antalgic medication during the stimulation: yes or no answer | measure the impact of the pain on the pregnancy project and on the analgesic management after stimulation between the 2 endometriosis - non-endometriosis groups | during the stimulation period (an average 10 days) | 
| willingness to take a antalgic medication during the punction: yes or no answer | measure the impact of the pain on the pregnancy project and on the analgesic management after stimulation between the 2 endometriosis - non-endometriosis groups | during the stimulation period (an average 10 days) | 

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