Evaluation of Pain in the Course of in Vitro Fertilization

Infertility Clinical Trial

— ENDALGOFIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04103320
• Other study ID #: 2018_45
• Secondary ID: 2019-A00555-52
• Status: Completed
• Start date: November 18, 2019
• Est. completion date: August 4, 2021

Study information

• Verified date: April 2022
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: August 4, 2021
• Est. primary completion date: August 4, 2021
• 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:

• 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	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
Primary	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
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)	one month after the IVF protocol
Primary	DN4	emotional and sensory dimension of pain, neuropathic pain survey in four questions - score on 7	one month after the IVF protocol
Primary	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
Primary	HAD,anxiety and depression	2 scores on 21 - "circle the number that best fits your condition"	one month after the IVF protocol
Primary	pain catastrophism scale (PCS)	score between 0 to 52	one month after the IVF protocol
Primary	heiQ = personal efficiency,	40 questions with 8 dimensions	one month after the IVF protocol
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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