InfertilityENDALGOFIVNCT04103320
Evaluation of Pain in the Course of in Vitro Fertilization
An observational study of Infertility, run by University Hospital, Lille at 1 site in France.
Trial 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. 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
- 318 participants
- Where
- 1 siteFrance
- Study dates
- 18 Nov 2019to 4 Aug 2021
- 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
- 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
Show all 10Show fewer
- 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
Official title: Evaluation of Pain in the Course of in Vitro Fertilization: the Endalgofiv Study
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.
- 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.
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).
composite criteria to assess of the typology of pain
Measured: one month after the IVF protocol
EN = numerical scale of pain
from 0 to 10 (0 is "no pain" and 10 is "maximum pain imaginable")
Measured: one month after the IVF protocol
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)
Measured: one month after the IVF protocol
DN4
emotional and sensory dimension of pain, neuropathic pain survey in four questions - score on 7
Measured: one month after the IVF protocol
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)
Measured: one month after the IVF protocol
HAD,anxiety and depression
2 scores on 21 - "circle the number that best fits your condition"
Measured: one month after the IVF protocol
pain catastrophism scale (PCS)
score between 0 to 52
Measured: one month after the IVF protocol
heiQ = personal efficiency,
40 questions with 8 dimensions
Measured: one month after the IVF protocol
Secondary outcomes (6)
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).
composite criteria to assess of the typology of pain
Measured: at Baseline (the first medical appointment) and 15 days after the embryo transfer
implantation rates (%)
measure in endometriotic and non-endometriotic patients,in primary and secondary infertility patients
Measured: at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle
pregnancy rate (%)
measure in endometriotic and non-endometriotic patients,in primary and secondary infertility patients
Measured: at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle
live birth rate (0 or 1)
measure in endometriotic and non-endometriotic patients,in primary and secondary infertility patients
Measured: at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle
renouncing a new IVF attempt: yes or no
measure the impact of pain on the pregnancy project in endometriotic and non-endometriotic patients,in primary and secondary infertility patients
Measured: at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle
willingness to take a specific treatment with an analgesic goal: yes or no answer
measure the impact of pain on the pregnancy project in endometriotic and non-endometriotic patients,in primary and secondary infertility patients
Measured: at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start18 Nov 2019
- Primary completion4 Aug 2021
- Study completion4 Aug 2021
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
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chrystelle Rubod, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103320
- Sponsor's protocol ID
- 2018_45
- Other IDs
- 2019-A00555-52
- Acronym
- ENDALGOFIV
- Status last verified
- Apr 2022
- First submitted
- 28 Aug 2019
- Last updated
- 29 Apr 2022
- 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 29 Apr 2022. 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 Study
- ClinicalTrials.gov ID
- NCT04103320
- Acronym / sponsor ID
- ENDALGOFIV / 2018_45
- Conditions
- Infertility
- Keywords
- Infertility, In Vitro Fertilization, Endometriosis, pain evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 4 Aug 2021 (actual)
- Study completion
- 4 Aug 2021 (actual)
- First posted
- 25 Sep 2019 (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.
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.
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 (10 listed)
- Refusal to participate in the study
- Minor patient
- Patient over 43 years old
- BMI patient > 35
- Pregnant woman
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
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
6 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
implantation rates (%)
Time frame: at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle
pregnancy rate (%)
Time frame: at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle
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
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
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
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 29 Apr 2022.
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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.
Chrystelle 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 10 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 29 Apr 2022. 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?
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). The study lists 8 primary outcomes in all. 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 29 Apr 2022.