Evaluation of Pain in the Course of in Vitro Fertilization

NCT ID: NCT04103320

Last Updated: 2022-04-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 318 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-18
• Study Completion Date: 2021-08-04

Brief 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. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chrystelle Rubod, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hop Jeanne de Flandre Chu Lille

Lille, , France

Countries

France

Other Identifiers

2019-A00555-52

Identifier Type: OTHER

Identifier Source: secondary_id

2018_45

Identifier Type: -

Identifier Source: org_study_id