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

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Other: Using different survey to evaluate pain

• Study Type: Observational
• Enrollment (Actual): 206

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hop Jeanne de Flandre Chu Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients who start an IVF cycle in the medically assisted procreation department of the Jeanne de Flandre Hospital (CHRU Lille)

Description

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 Plan

How is the study designed?

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)

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Chrystele Rubod, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Actual): March 24, 2024
• Study Completion (Actual): March 24, 2024

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: October 20, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Infertility; In Vitro Fertilization; Endometriosis; pain evaluation
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Infertility; Endometriosis
• Other Study ID Numbers: 2022_0015; 2022-A01468-35 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No