Completed

NCT Number: NCT04103320

Evaluation of Pain in the Course of in Vitro Fertilization

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.

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Key information

Conditions

Infertility Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–43 year

Sex eligibility

Female

Study type

Observational

Primary location

Hop Jeanne de Flandre Chu Lille

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Using different survey to evaluate pain

Other

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)

Primary outcomes

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).

Time frame: one month after the IVF protocol

composite criteria to assess of the typology of pain
EN = numerical scale of pain

Time frame: one month after the IVF protocol

from 0 to 10 (0 is "no pain" and 10 is "maximum pain imaginable")
Questionnaire douleur Saint Antoine (QDSA)

Time frame: 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)
DN4

Time frame: one month after the IVF protocol

emotional and sensory dimension of pain, neuropathic pain survey in four questions - score on 7
EQ-5D quality of life

Time frame: 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)
HAD,anxiety and depression

Time frame: one month after the IVF protocol

2 scores on 21 - "circle the number that best fits your condition"
pain catastrophism scale (PCS)

Time frame: one month after the IVF protocol

score between 0 to 52
heiQ = personal efficiency,

Time frame: one month after the IVF protocol

40 questions with 8 dimensions

Secondary outcomes

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).

Time frame: at Baseline (the first medical appointment) and 15 days after the embryo transfer

composite criteria to assess of the typology of pain
implantation rates (%)

Time frame: 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 (%)

Time frame: 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
live birth rate (0 or 1)

Time frame: 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

Time frame: 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
willingness to take a specific treatment with an analgesic goal: yes or no answer

Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: ENDALGOFIV

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Sep 25, 2019
Registry last updated: Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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