Evaluation of Pain in the Course of in Vitro Fertilization

Completed

• Conditions: Infertility

• Registration Number: NCT04103320
• Lead Sponsor: University Hospital, Lille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-28
• Study First Submitted QC: 2019-09-23
• Study First Posted: 2019-09-25
• Study Start: 2019-11-18
• Primary Completion: 2021-08-04
• Study Completion: 2021-08-04
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-28
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 318

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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).	at Baseline (the first medical appointment) and 15 days after the embryo transfer	composite criteria to assess of the typology of pain
willingness to take a specific treatment with an analgesic goal: yes or no answer	at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle	measure the impact of pain on the pregnancy project in endometriotic and non-endometriotic patients,in primary and secondary infertility patients
live birth rate (0 or 1)	at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle	measure in endometriotic and non-endometriotic patients,in primary and secondary infertility patients
pregnancy rate (%)	at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle	measure in endometriotic and non-endometriotic patients,in primary and secondary infertility patients
implantation rates (%)	at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle	measure in endometriotic and non-endometriotic patients,in primary and secondary infertility patients
renouncing a new IVF attempt: yes or no	at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle	measure the impact of pain on the pregnancy project in endometriotic and non-endometriotic patients,in primary and secondary infertility patients

Trial Locations

Locations (1)

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