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CompletedNCT05591521ENDALGOFIV-2Updated Dec 26, 2025

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

An observational study in Infertility, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to female participants aged 18 Years to 43 Years. Per ClinicalTrials.gov, last updated 2025-12-26.

Sponsored by University Hospital, Lille · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
206
Ages
18 Years to 43 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Infertility

Keywords

  • Infertility
  • In Vitro Fertilization
  • Endometriosis
  • pain evaluation
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 206 is close to the median of 200 across 714 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 43 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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)

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
206 participants (actual)
Patient registry
No

Interventions

  • OtherUsing 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)

06

What researchers measure

Primary outcomes

  1. 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). Scored from 0 to 64

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

Secondary outcomes

  1. Questionnaire douleur Saint Antoine (QDSA)

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

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

  2. EN = numerical scale of pain

    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

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

  3. DN4

    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

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

  4. HAD,anxiety and depression

    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)

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

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

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

  6. pain catastrophism scale (PCS)

    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)

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

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

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

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

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

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

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

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

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

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

07

Study locations

1 site
  • Hop Jeanne de Flandre Chu Lille
    Lille, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05591521
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Oct 24, 2022
Start date
Nov 30, 2022
Primary completion
Mar 24, 2024
Completion
Mar 24, 2024
Last update
Dec 26, 2025

Study contacts

Chrystele Rubod, MD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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