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

NCT ID: NCT05591521

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

206 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-30

Study Completion Date

2024-03-24

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility

Keywords

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Infertility In Vitro Fertilization Endometriosis pain evaluation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Using 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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chrystele Rubod, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hop Jeanne de Flandre Chu Lille

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2022-A01468-35

Identifier Type: OTHER

Identifier Source: secondary_id

2022_0015

Identifier Type: -

Identifier Source: org_study_id