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

• Conditions: Infertility

• Registration Number: NCT05591521
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-10-20
• Last Update Submitted: 2022-10-20
• Study First Posted: 2022-10-24
• Last Update Posted: 2022-10-24
• Study Start: 2022-12
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 206

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Questionnaire douleur Saint Antoine (QDSA)	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

Secondary Outcome Measures

Name	Time	Method
HAD,anxiety and depression	At baseline and during procedure ( an average up to 6 weeks)	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)
pain catastrophism scale (PCS)	At baseline and during procedure ( an average up to 6 weeks)	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)
Questionnaire douleur Saint Antoine (QDSA)	At baseline and during procedure ( an average up to 6 weeks)	compare the evolution of pain during study between the 2 groups endometriosis - non endometriosis
DN4	At baseline and during procedure ( an average up to 6 weeks)	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
willingness to go the pain consultation: yes or no answer	during the stimulation period (an average 10 days)	measure the impact of the pain on the pregnancy project and on the analgesic management after stimulation between the 2 endometriosis - non-endometriosis groups
EN = numerical scale of pain	At baseline and during procedure ( an average up to 6 weeks)	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
EQ-5D quality of life	At baseline and during procedure ( an average up to 6 weeks)	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)
willingness to take a antalgic medication during the stimulation: yes or no answer	during the stimulation period (an average 10 days)	measure the impact of the pain on the pregnancy project and on the analgesic management after stimulation between the 2 endometriosis - non-endometriosis groups
willingness to take a antalgic medication during the punction: yes or no answer	during the stimulation period (an average 10 days)	measure the impact of the pain on the pregnancy project and on the analgesic management after stimulation between the 2 endometriosis - non-endometriosis groups

Trial Locations

Locations (1)

Hop Jeanne de Flandre Chu Lille; 🇫🇷 Lille, France