Evaluation of Pain in the Course of in Vitro Fertilization (ENDALGOFIV)

April 28, 2022 updated by: University Hospital, Lille

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
318

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • Hop Jeanne de Flandre Chu Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
one month after the IVF protocol
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")
one month after the IVF protocol
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)
one month after the IVF protocol
DN4
Time Frame: one month after the IVF protocol
emotional and sensory dimension of pain, neuropathic pain survey in four questions - score on 7
one month after the IVF protocol
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)
one month after the IVF protocol
HAD,anxiety and depression
Time Frame: one month after the IVF protocol
2 scores on 21 - "circle the number that best fits your condition"
one month after the IVF protocol
pain catastrophism scale (PCS)
Time Frame: one month after the IVF protocol
score between 0 to 52
one month after the IVF protocol
heiQ = personal efficiency,
Time Frame: one month after the IVF protocol
40 questions with 8 dimensions
one month after the IVF protocol

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
measure in endometriotic and non-endometriotic patients,in primary and secondary infertility patients
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
measure in endometriotic and non-endometriotic patients,in primary and secondary infertility patients
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
measure in endometriotic and non-endometriotic patients,in primary and secondary infertility patients
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
measure the impact of pain on the pregnancy project in endometriotic and non-endometriotic patients,in primary and secondary infertility patients
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
measure the impact of pain on the pregnancy project in endometriotic and non-endometriotic patients,in primary and secondary infertility patients
at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Lille

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chrystelle Rubod, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 18, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 4, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 4, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018_45
  • 2019-A00555-52 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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