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

Infertility Clinical Trial

— ENDALGOFIV-2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05591521
• Other study ID #: 2022_0015
• Secondary ID: 2022-A01468-35
• Status: Not yet recruiting
• Start date: December 2022
• Est. completion date: March 2024

Study information

• Verified date: August 2022
• Source: University Hospital, Lille
• Contact: Chrystele Rubod, MD
• Phone: 03 20 44 67 57
• Email: chrystele.rubod[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 206
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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)

Locations

Country	Name	City	State
France	Hop Jeanne de Flandre Chu Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)