Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-01-28 @ 10:39 PM
Study NCT ID:
NCT04103320
Status:
COMPLETED
Last Update Posted:
2022-04-29
First Post:
2019-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Pain in the Course of in Vitro Fertilization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}, {'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 318}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-28', 'studyFirstSubmitDate': '2019-08-28', 'studyFirstSubmitQcDate': '2019-09-23', 'lastUpdatePostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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).', 'timeFrame': 'one month after the IVF protocol', 'description': 'composite criteria to assess of the typology of pain'}, {'measure': 'EN = numerical scale of pain', 'timeFrame': 'one month after the IVF protocol', 'description': 'from 0 to 10 (0 is "no pain" and 10 is "maximum pain imaginable")'}, {'measure': 'Questionnaire douleur Saint Antoine (QDSA)', 'timeFrame': 'one month after the IVF protocol', 'description': "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)"}, {'measure': 'DN4', 'timeFrame': 'one month after the IVF protocol', 'description': 'emotional and sensory dimension of pain, neuropathic pain survey in four questions - score on 7'}, {'measure': 'EQ-5D quality of life', 'timeFrame': 'one month after the IVF protocol', 'description': '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)'}, {'measure': 'HAD,anxiety and depression', 'timeFrame': 'one month after the IVF protocol', 'description': '2 scores on 21 - "circle the number that best fits your condition"'}, {'measure': 'pain catastrophism scale (PCS)', 'timeFrame': 'one month after the IVF protocol', 'description': 'score between 0 to 52'}, {'measure': 'heiQ = personal efficiency,', 'timeFrame': 'one month after the IVF protocol', 'description': '40 questions with 8 dimensions'}], 'secondaryOutcomes': [{'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).', 'timeFrame': 'at Baseline (the first medical appointment) and 15 days after the embryo transfer', 'description': 'composite criteria to assess of the typology of pain'}, {'measure': 'implantation rates (%)', 'timeFrame': 'at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle', 'description': 'measure in endometriotic and non-endometriotic patients,in primary and secondary infertility patients'}, {'measure': 'pregnancy rate (%)', 'timeFrame': 'at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle', 'description': 'measure in endometriotic and non-endometriotic patients,in primary and secondary infertility patients'}, {'measure': 'live birth rate (0 or 1)', 'timeFrame': 'at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle', 'description': 'measure in endometriotic and non-endometriotic patients,in primary and secondary infertility patients'}, {'measure': 'renouncing a new IVF attempt: yes or no', 'timeFrame': 'at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle', 'description': 'measure the impact of pain on the pregnancy project in endometriotic and non-endometriotic patients,in primary and secondary infertility patients'}, {'measure': 'willingness to take a specific treatment with an analgesic goal: yes or no answer', 'timeFrame': 'at Baseline (the first medical appointment), 15 days after embryo transfer, and at one month of the IVF cycle', 'description': 'measure the impact of pain on the pregnancy project in endometriotic and non-endometriotic patients,in primary and secondary infertility patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infertility', 'In Vitro Fertilization', 'Endometriosis', 'pain evaluation'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who start an IVF cycle in the medically assisted procreation department of the Jeanne de Flandre Hospital (CHRU Lille)', 'genderDescription': 'All patients who start an IVF cycle in the medically assisted procreation department of the Jeanne de Flandres Hospital (CHRU Lille)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who start an IVF cycle in the medically assisted procreation department of the Jeanne de Flandres Hospital (CHRU Lille)\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* Minor patient\n* Patient over 43 years old\n* BMI patient \\> 35\n* Pregnant woman\n* Unable to provide clear information to the patient\n* Patient under guardianship or lack of health cover\n* Patient in IVF with donation of oocyte\n* IVF patients for oocyte preservation\n* Patient who had already participated in the study'}, 'identificationModule': {'nctId': 'NCT04103320', 'acronym': 'ENDALGOFIV', 'briefTitle': 'Evaluation of Pain in the Course of in Vitro Fertilization', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Evaluation of Pain in the Course of in Vitro Fertilization: the Endalgofiv Study', 'orgStudyIdInfo': {'id': '2018_45'}, 'secondaryIdInfos': [{'id': '2019-A00555-52', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Using different survey to evaluate pain', 'type': 'OTHER', 'description': '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)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'Hop Jeanne de Flandre Chu Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Chrystelle Rubod, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}