Clinical trial NCT04103320: Evaluation of Pain in the Course of in Vitro Fertilization
Official title: Evaluation of Pain in the Course of in Vitro Fertilization: the Endalgofiv Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: Infertility
In Vitro Fertilization
Endometriosis
pain evaluation
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 318
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: 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.


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:

* 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: 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).
timeFrame: one month after the IVF protocol
measure: EN = numerical scale of pain
timeFrame: one month after the IVF protocol
measure: Questionnaire douleur Saint Antoine (QDSA)
timeFrame: one month after the IVF protocol
measure: DN4
timeFrame: one month after the IVF protocol
measure: EQ-5D quality of life
timeFrame: one month after the IVF protocol
measure: HAD,anxiety and depression
timeFrame: one month after the IVF protocol
measure: pain catastrophism scale (PCS)
timeFrame: one month after the IVF protocol
measure: heiQ = personal efficiency,
timeFrame: one month after the IVF protocol
Secondary outcomes:
measure: 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).
timeFrame: at Baseline (the first medical appointment) and 15 days after the embryo transfer
measure: implantation rates (%)
timeFrame: at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle
measure: pregnancy rate (%)
timeFrame: at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle
measure: live birth rate (0 or 1)
timeFrame: at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle
measure: renouncing a new IVF attempt: yes or no
timeFrame: at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle
measure: willingness to take a specific treatment with an analgesic goal: yes or no answer
timeFrame: at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Jeanne de Flandre Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Chrystelle Rubod, MD
role: PRINCIPAL_INVESTIGATOR
References: