Evaluation of Pain in the Course of in Vitro Fertilization (ENDALGOFIV)

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

25 to 50% of endometriotic patients are infertile and use medically assisted procreation. In general, the assessment of pain in medically assisted procreation is very little studied. Pain assessment studies in endometriotic patients remain limited to a quantitative assessment of pain symptomatology, without contextualization of painful manifestations. The primary objective of our study is the qualitative and contextualized assessment of pain during In Vitro Fertilization (IVF) protocol in endometriotic and non-endometriotic patients. The secondary objectives of our study are the quantitative study of pain, the measurement of the impact of personal efficiency on painful symptomatology, evaluation of depression, the results of IVF (implantation, pregnancy and live birth rates), and compare pain between endometriotic or non-endometriotic patients and between primary infertility and secondary infertility. According to the results obtained in this study, therapeutic strategies for the management of pain could be proposed, with the aim of improving the quality of life and the results of IVF in these patients.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 318

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
• Genders Eligible for Study: Female

• 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:

• 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?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the scores obtained by the pain survey (EN, QDSA, DN4), quality of life survey (EQ-5D), depression and anxiety (HAD), pain catastrophism score (PCS) and assessment of personal efficacy (heiQ).	composite criteria to assess of the typology of pain	one month after the IVF protocol
EN = numerical scale of pain	from 0 to 10 (0 is "no pain" and 10 is "maximum pain imaginable")	one month after the IVF protocol
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)	one month after the IVF protocol
DN4	emotional and sensory dimension of pain, neuropathic pain survey in four questions - score on 7	one month after the IVF protocol
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)	one month after the IVF protocol
HAD,anxiety and depression	2 scores on 21 - "circle the number that best fits your condition"	one month after the IVF protocol
pain catastrophism scale (PCS)	score between 0 to 52	one month after the IVF protocol
heiQ = personal efficiency,	40 questions with 8 dimensions	one month after the IVF protocol

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the scores obtained by the pain survey (EN, QDSA, DN4), quality of life survey (EQ-5D), depression and anxiety (HAD), pain catastrophism score (PCS) and assessment of personal efficacy (heiQ).	composite criteria to assess of the typology of pain	at Baseline (the first medical appointment) and 15 days after the embryo transfer
implantation rates (%)	measure in endometriotic and non-endometriotic patients,in primary and secondary infertility patients	at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle
pregnancy rate (%)	measure in endometriotic and non-endometriotic patients,in primary and secondary infertility patients	at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle
live birth rate (0 or 1)	measure in endometriotic and non-endometriotic patients,in primary and secondary infertility patients	at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle
renouncing a new IVF attempt: yes or no	measure the impact of pain on the pregnancy project in endometriotic and non-endometriotic patients,in primary and secondary infertility patients	at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle
willingness to take a specific treatment with an analgesic goal: yes or no answer	measure the impact of pain on the pregnancy project in endometriotic and non-endometriotic patients,in primary and secondary infertility patients	at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2019
• Primary Completion (Actual): August 4, 2021
• Study Completion (Actual): August 4, 2021

Study Registration Dates

• First Submitted: August 28, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Infertility; In Vitro Fertilization; Endometriosis; pain evaluation
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 2018_45; 2019-A00555-52 (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