Evaluation of Pain in the Course of in Vitro Fertilization

NCT04103320 | Completed

• 2 other identifiers: 2018_452019-A00555-52
• Study Type: observational
• Target: 318
• Locations: 1 country
• Sites: 1

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

Keywords

Infertility; In Vitro Fertilization; Endometriosis; pain evaluation

Outcome Measures

Primary Outcomes (8)

• 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

  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")

  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)

  one month after the IVF protocol

• DN4

  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

  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

  2 scores on 21 - "circle the number that best fits your condition"

  one month after the IVF protocol

• pain catastrophism scale (PCS)

  score between 0 to 52

  one month after the IVF protocol

• heiQ = personal efficiency,

  40 questions with 8 dimensions

  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).

  at Baseline (the first medical appointment) and 15 days after the embryo transfer

• implantation rates (%)

  at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle

• pregnancy rate (%)

  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)

  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

  at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle

Interventions

Using different survey to evaluate pain OTHER

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)

Eligibility Criteria

• Age: 18 Years - 43 Years
• Gender Eligibility Details: All patients who start an IVF cycle in the medically assisted procreation department of the Jeanne de Flandres Hospital (CHRU Lille)
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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)

You may qualify if:

• All patients who start an IVF cycle in the medically assisted procreation department of the Jeanne de Flandres Hospital (CHRU Lille)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Jeanne de Flandre Chu Lille

Lille, France

Location

MeSH Terms

Conditions

Infertility; Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Chrystelle Rubod, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 25, 2019
• Study Start: November 18, 2019
• Primary Completion: August 4, 2021
• Study Completion: August 4, 2021
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

FR (1)