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NCT Number: NCT05591521

Evaluation of Pain in the Course of in Vitro Fertilization: the Endalgofiv-2 Study

The ENDALGOFIV study of pain assessment during the IVF pathway at Lille University Hospital, conducted from November 2018 to July 2020, showed that endometriosis patients have intense pain, particularly of a neuropathic nature, even before starting their IVF pathway compared to patients without endometriosis, but without an increase in pain scores during the IVF pathway. As a result of this study, a new pain management protocol for all patients undergoing IVF have been implemented in our MPA center. The study will be evaluated the impact of this new management.

Main objective To evaluate the effect of the change in pain management protocol in all patients (endometriotic or not) undergoing IVF treatment during the study period by comparing them to the data of the ENDALGOFIV 1 study.

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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

  • Previously enrolled patient (ENDALGOFIV or ENDALGOFIV 2)
  • 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

  1. Questionnaire douleur Saint Antoine (QDSA)

    Time frame: After puncture, before discharge from hospital (assessed up to 24 hours)

    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). Scored from 0 to 64

Secondary outcomes

  1. Questionnaire douleur Saint Antoine (QDSA)

    Time frame: At baseline and during procedure ( an average up to 6 weeks)

    compare the evolution of pain during study between the 2 groups endometriosis - non endometriosis

  2. EN = numerical scale of pain

    Time frame: At baseline and during procedure ( an average up to 6 weeks)

    from 0 to 10 (0 is "no pain" and 10 is "maximum pain imaginable") compare the evolution of pain during study between the 2 groups endometriosis - non endometriosis

  3. DN4

    Time frame: At baseline and during procedure ( an average up to 6 weeks)

    emotional and sensory dimension of pain, neuropathic pain survey in four questions - score on 7 compare the evolution of pain during study between the 2 groups endometriosis - non endometriosis

  4. HAD,anxiety and depression

    Time frame: At baseline and during procedure ( an average up to 6 weeks)

    2 scores on 21 - "circle the number that best fits your condition" Compare the evolution of pain during study according to the 2 periods (ENDALGOFIV 1 patients and patients who benefited from the new management protocol)

  5. EQ-5D quality of life

    Time frame: At baseline and during procedure ( an average up to 6 weeks)

    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) Compare the evolution of pain during study according to the 2 periods (ENDALGOFIV 1 patients and patients who benefited from the new management protocol)

  6. pain catastrophism scale (PCS)

    Time frame: At baseline and during procedure ( an average up to 6 weeks)

    score between 0 to 52. Compare the evolution of pain during study according to the 2 periods (ENDALGOFIV 1 patients and patients who benefited from the new management protocol)

  7. willingness to go the pain consultation: yes or no answer

    Time frame: during the stimulation period (an average 10 days)

    measure the impact of the pain on the pregnancy project and on the analgesic management after stimulation between the 2 endometriosis - non-endometriosis groups

  8. willingness to take a antalgic medication during the stimulation: yes or no answer

    Time frame: during the stimulation period (an average 10 days)

    measure the impact of the pain on the pregnancy project and on the analgesic management after stimulation between the 2 endometriosis - non-endometriosis groups

  9. willingness to take a antalgic medication during the punction: yes or no answer

    Time frame: during the stimulation period (an average 10 days)

    measure the impact of the pain on the pregnancy project and on the analgesic management after stimulation between the 2 endometriosis - non-endometriosis groups

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: ENDALGOFIV-2

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2022
Registry last updated
Dec 26, 2025

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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