Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2025-12-25 @ 5:19 PM
Study NCT ID:
NCT01187095
Status:
COMPLETED
Last Update Posted:
2021-06-16
First Post:
2010-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Involuntary Childlessness and Stress Management
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yoonf@psy.au.dk', 'phone': '+4587565871', 'title': 'Yoon Frederiksen', 'organization': 'Aarhus University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '20 months', 'eventGroups': [{'id': 'EG000', 'title': 'Counselling', 'description': 'Do couples in IVF treatment benefit from emotional disclosure\n\nExpressive writing: 3 consecutive days of writing', 'otherNumAtRisk': 108, 'deathsNumAtRisk': 108, 'otherNumAffected': 0, 'seriousNumAtRisk': 108, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Neutral writing exercise\n\nActive ctrl: Control', 'otherNumAtRisk': 108, 'deathsNumAtRisk': 108, 'otherNumAffected': 0, 'seriousNumAtRisk': 108, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Effect of Expressive Writing Intervention on Fertility Related Stress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Counselling', 'description': 'Do couples in IVF treatment benefit from emotional disclosure\n\nExpressive writing: 3 consecutive days of writing'}, {'id': 'OG001', 'title': 'Control', 'description': 'Neutral writing exercise\n\nActive ctrl: Control'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '17.2', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '15.7', 'spread': '9.1', 'groupId': 'OG001'}]}]}, {'title': 'Follow up 1', 'categories': [{'measurements': [{'value': '17.4', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '17.1', 'spread': '9.8', 'groupId': 'OG001'}]}]}, {'title': 'Follow up 2', 'categories': [{'measurements': [{'value': '18.7', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '17.6', 'spread': '10.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Estimation parameter'}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'follow-up 2 (3 months)', 'description': "The COMPI 14-item self-rating instrument has been developed to capture specific thoughts and feelings in relation to involuntarily childlessness, which may lead to distress on 4-point and 5-point Likert scales. Responses cover personal, social, and marital domains with total scores ranging between 14 - 38, and higher scores indicating higher levels of infertility-related distress. Internal consistency (Cronbach's alpha) in the present study was 0.89 and the baseline to post-intervention test-retest correlation was 0.84. For the sub-domains the reliability of the scales were as follows; personal domain α=0.86, social domain α=0.83 and marital domain α=0.73.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Couples undergoing IVF or ICSI fertility treatment'}, {'type': 'SECONDARY', 'title': 'Pregnancy Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Counselling', 'description': 'Do couples in IVF treatment benefit from emotional disclosure\n\nExpressive writing: 3 consecutive days of writing'}, {'id': 'OG001', 'title': 'Control', 'description': 'Neutral writing exercise\n\nActive ctrl: Control'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'measured at follow-up (t3) 3 months', 'description': 'How many women achieved pregnancy in each arm', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Counselling', 'description': 'Do couples in IVF treatment benefit from emotional disclosure\n\nExpressive writing: 3 consecutive days of writing'}, {'id': 'FG001', 'title': 'Control', 'description': 'Neutral writing exercise\n\nActive ctrl: Control'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '142'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '108'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '34'}]}]}], 'recruitmentDetails': 'Couples were recruited from November 2010 through July 2012. Recruitment took place at the following three Danish fertility clinics: The Fertility Clinic at Aarhus University Hospital, Skive Fertility Clinic, Skive; Brædstrup Fertility Clinic, Brædstrup.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Counselling', 'description': 'Does couples in IVF treatment benefit from emotional disclosure\n\nExpressive writing: 3 consecutive days of writing'}, {'id': 'BG001', 'title': 'Control', 'description': 'Neutral writing exercise\n\nActive ctrl: Control'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Women', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31.9', 'spread': '4.4', 'groupId': 'BG000'}, {'value': '32.9', 'spread': '4.8', 'groupId': 'BG001'}, {'value': '32.3', 'spread': '4.5', 'groupId': 'BG002'}]}]}, {'title': 'Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '33.9', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '34.7', 'spread': '6.2', 'groupId': 'BG001'}, {'value': '34.3', 'spread': '6.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The rows indicate the age dependent on gender'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Self-reported data', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Denmark', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 298}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-14', 'studyFirstSubmitDate': '2010-07-09', 'resultsFirstSubmitDate': '2018-03-02', 'studyFirstSubmitQcDate': '2010-08-20', 'lastUpdatePostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-02', 'studyFirstPostDateStruct': {'date': '2010-08-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Effect of Expressive Writing Intervention on Fertility Related Stress', 'timeFrame': 'follow-up 2 (3 months)', 'description': "The COMPI 14-item self-rating instrument has been developed to capture specific thoughts and feelings in relation to involuntarily childlessness, which may lead to distress on 4-point and 5-point Likert scales. Responses cover personal, social, and marital domains with total scores ranging between 14 - 38, and higher scores indicating higher levels of infertility-related distress. Internal consistency (Cronbach's alpha) in the present study was 0.89 and the baseline to post-intervention test-retest correlation was 0.84. For the sub-domains the reliability of the scales were as follows; personal domain α=0.86, social domain α=0.83 and marital domain α=0.73."}], 'secondaryOutcomes': [{'measure': 'Pregnancy Rate', 'timeFrame': 'measured at follow-up (t3) 3 months', 'description': 'How many women achieved pregnancy in each arm'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Involuntary childlessness', 'Infertility', 'IVF', 'EWI', 'Couples in IVF treatment', 'Psychosocial intervention'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '34949542', 'type': 'DERIVED', 'citation': 'Philipsen MT, Knudsen UB, Zachariae R, Ingerslev HJ, Hvidt JEM, Frederiksen Y. Sleep, psychological distress, and clinical pregnancy outcome in women and their partners undergoing in vitro or intracytoplasmic sperm injection fertility treatment. Sleep Health. 2022 Apr;8(2):242-248. doi: 10.1016/j.sleh.2021.10.011. Epub 2021 Dec 20.'}, {'pmid': '28007790', 'type': 'DERIVED', 'citation': "Frederiksen Y, O'Toole MS, Mehlsen MY, Hauge B, Elbaek HO, Zachariae R, Ingerslev HJ. The effect of expressive writing intervention for infertile couples: a randomized controlled trial. Hum Reprod. 2017 Feb;32(2):391-402. doi: 10.1093/humrep/dew320. Epub 2016 Dec 21."}]}, 'descriptionModule': {'briefSummary': 'Many couples experience involuntary childlessness and seek treatment at fertility clinics. Going through treatment procedures can be very challenging, time consuming and emotionally demanding.\n\nPsychosocial intervention might have a soothing and healing effect on both behavior as well on physical matters. Hence, the investigators would like to investigate whether Expressive Writing Intervention (EWI) has an effect on stress management as well as on the pregnancy rate for couples who are going through fertility treatment.', 'detailedDescription': 'Background:\n\nAround 10-14 % of all couples are experiencing involuntary childlessness. Most of these couples will be referred to the public health clinics in order to receive help by means of fertility treatment e.g. in vitro fertility (IVF) and numbers from the National board of Health indicates that the number is rising. It is well known that involuntary childlessness pose an enduring psychosocial burden and strain with feelings of hopelessness, despair, anger and frustration as well as anxiety and sadness. Much research points out that couples that receive IVF treatment to a great extent often experience stress and strong emotional oscillations during the treatment procedures. Some studies indicate that negative feelings as described above might have a negative impact on the chances of becoming pregnant. In spite of these findings there are only conducted very few controlled studies of intervention with this patient group, which might explain why it is still unclear whether infertile couples can benefit from therapeutic intervention.\n\nA growing number of studies in the area of health psychology has suggested that interventions where the participants has the opportunity to express themselves in writing about feelings, so-called Expressive Writing Intervention (EWI) seem to have a positive effect on physical health as well as mental well-being.\n\nMethods:\n\nCouples starting with their IVF treatment at the Fertility Clinic, Skejby Hospital will be invited to participate in the research project. Approximately 400 couples are expected to begin treatment during a one year period (We would like to enrol at least 144 couples). They will be randomized into a EWI group (writing about fertility related topics - emotional disclosure) and a control group (writing about neutral topics non-emotional disclosure).\n\nInclusion criteria:\n\n* Heterosexual couples as well as Homosexual couples\n* 1st, 2nd and 3rd treatment cycles\n* Can read and understand Danish\n* Aged 18-40 years\n\nExclusion criteria:\n\n• Patients with genetic diseases (PGD patients)\n\nThe investigators would like to know more about whether EWI has an effect on:\n\n1. The extent of psychosocial strain - does change happen in life satisfaction, emotional state and reactions, as well as with thoughts about childlessness and treatment.\n2. The result of the IVF treatment (pregnancy/non pregnancy)\n3. The adaptation to the (negative) treatment outcome - the impact of having participated in an EWI intervention group.\n\nFurthermore mediators and moderators will be explored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* heterosexual couples lesbian couples\n\nExclusion Criteria:\n\n* couples; where one of them suffers from a genetic disease'}, 'identificationModule': {'nctId': 'NCT01187095', 'briefTitle': 'Involuntary Childlessness and Stress Management', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'A Randomized Controlled Intervention Study: The Effect of Expressive Writing on Psychosocial Stress and Pregnancy Results With Couples Undergoing In Vitro Fertility(IVF) Treatment Due to Involuntary Childlessness.', 'orgStudyIdInfo': {'id': 'EWI-2008-41-1869'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'counselling', 'description': 'Does couples in IVF treatment benefit from emotional disclosure', 'interventionNames': ['Behavioral: Expressive writing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Neutral writing exercise', 'interventionNames': ['Behavioral: Active ctrl']}], 'interventions': [{'name': 'Expressive writing', 'type': 'BEHAVIORAL', 'otherNames': ['EWI'], 'description': '3 consecutive days of writing', 'armGroupLabels': ['counselling']}, {'name': 'Active ctrl', 'type': 'BEHAVIORAL', 'description': 'Control', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'state': 'Jylland', 'country': 'Denmark', 'facility': 'Department of Psychology, Aarhus University', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Bobby Zachariae, prof.med.,', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aarhus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD.-fellowship', 'investigatorFullName': 'Yoon Frederiksen', 'investigatorAffiliation': 'University of Aarhus'}}}}