InfertilityENDALGOFIV-2NCT05591521
Evaluation of Pain in the Course of in Vitro Fertilization: the Endalgofiv-2 Study
An observational study of Infertility, run by University Hospital, Lille at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Using different survey to evaluate pain
- How many people
- 206 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2022to 24 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Study population: All patients who start an IVF cycle in the medically assisted procreation department of the Jeanne de Flandre Hospital (CHRU Lille)
Who may be able to join
- All patients who start an IVF cycle in the medically assisted procreation department of the Jeanne de Flandres Hospital (CHRU Lille)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Infertility
- Being tested
- Using different survey to evaluate pain
- Keywords
- Infertility, In Vitro Fertilization, Endometriosis, pain evaluation
- Medical subject headings
- Infertility, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using different survey to evaluate painOther
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After puncture, before discharge from hospital (assessed up to 24 hours)
Secondary outcomes (9)
Questionnaire douleur Saint Antoine (QDSA)
compare the evolution of pain during study between the 2 groups endometriosis - non endometriosis
Measured: At baseline and during procedure ( an average up to 6 weeks)
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
Measured: At baseline and during procedure ( an average up to 6 weeks)
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
Measured: At baseline and during procedure ( an average up to 6 weeks)
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)
Measured: At baseline and during procedure ( an average up to 6 weeks)
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)
Measured: At baseline and during procedure ( an average up to 6 weeks)
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)
Measured: At baseline and during procedure ( an average up to 6 weeks)
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
Measured: during the stimulation period (an average 10 days)
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
Measured: during the stimulation period (an average 10 days)
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
Measured: during the stimulation period (an average 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start30 Nov 2022
- Primary completion24 Mar 2024
- Study completion24 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chrystele Rubod, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591521
- Sponsor's protocol ID
- 2022_0015
- Other IDs
- 2022-A01468-35
- Acronym
- ENDALGOFIV-2
- Status last verified
- Dec 2025
- First submitted
- 11 Aug 2022
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain in the Course of in Vitro Fertilization: the Endalgofiv-2 Study
- ClinicalTrials.gov ID
- NCT05591521
- Acronym / sponsor ID
- ENDALGOFIV-2 / 2022_0015
- Conditions
- Infertility
- Keywords
- Infertility, In Vitro Fertilization, Endometriosis, pain evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 24 Mar 2024 (actual)
- Study completion
- 24 Mar 2024 (actual)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All patients who start an IVF cycle in the medically assisted procreation department of the Jeanne de Flandre Hospital (CHRU Lille)
Key inclusion criteria (1 listed)
- All patients who start an IVF cycle in the medically assisted procreation department of the Jeanne de Flandres Hospital (CHRU Lille)
Key exclusion criteria (11 listed)
- Previously enrolled patient (ENDALGOFIV or ENDALGOFIV 2)
- Refusal to participate in the study
- Minor patient
- Patient over 43 years old
- BMI patient > 35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Using different survey to evaluate painSurvey 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) | Other | – |
Primary outcome
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
9 secondary outcomes
Questionnaire douleur Saint Antoine (QDSA)
Time frame: At baseline and during procedure ( an average up to 6 weeks)
EN = numerical scale of pain
Time frame: At baseline and during procedure ( an average up to 6 weeks)
DN4
Time frame: At baseline and during procedure ( an average up to 6 weeks)
HAD,anxiety and depression
Time frame: At baseline and during procedure ( an average up to 6 weeks)
EQ-5D quality of life
Time frame: At baseline and during procedure ( an average up to 6 weeks)
pain catastrophism scale (PCS)
Time frame: At baseline and during procedure ( an average up to 6 weeks)
willingness to go the pain consultation: yes or no answer
Time frame: during the stimulation period (an average 10 days)
willingness to take a antalgic medication during the stimulation: yes or no answer
Time frame: during the stimulation period (an average 10 days)
willingness to take a antalgic medication during the punction: yes or no answer
Time frame: during the stimulation period (an average 10 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chrystele Rubod, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire douleur Saint Antoine (QDSA) (time frame: After puncture, before discharge from hospital (assessed up to 24 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.