Clinical trial NCT05591521: Evaluation of Pain in the Course of in Vitro Fertilization: the Endalgofiv-2 Study
Official title: Evaluation of Pain in the Course of in Vitro Fertilization: the Endalgofiv-2 Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Keywords: Infertility
In Vitro Fertilization
Endometriosis
pain evaluation
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 206
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.


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

Primary outcomes:
measure: Questionnaire douleur Saint Antoine (QDSA)
timeFrame: After puncture, before discharge from hospital (assessed up to 24 hours)
Secondary outcomes:
measure: Questionnaire douleur Saint Antoine (QDSA)
timeFrame: At baseline and during procedure ( an average up to 6 weeks)
measure: EN = numerical scale of pain
timeFrame: At baseline and during procedure ( an average up to 6 weeks)
measure: DN4
timeFrame: At baseline and during procedure ( an average up to 6 weeks)
measure: HAD,anxiety and depression
timeFrame: At baseline and during procedure ( an average up to 6 weeks)
measure: EQ-5D quality of life
timeFrame: At baseline and during procedure ( an average up to 6 weeks)
measure: pain catastrophism scale (PCS)
timeFrame: At baseline and during procedure ( an average up to 6 weeks)
measure: willingness to go the pain consultation: yes or no answer
timeFrame: during the stimulation period (an average 10 days)
measure: willingness to take a antalgic medication during the stimulation: yes or no answer
timeFrame: during the stimulation period (an average 10 days)
measure: willingness to take a antalgic medication during the punction: yes or no answer
timeFrame: during the stimulation period (an average 10 days)
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Jeanne de Flandre Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Chrystele Rubod, MD
role: PRINCIPAL_INVESTIGATOR
References: