NCT01187095

Brief Summary

Many couples experience involuntary childlessness and seek treatment at fertility clinics. Going through treatment procedures can be very challenging, time consuming and emotionally demanding. Psychosocial 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
298

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 23, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
8.2 years until next milestone

Results Posted

Study results publicly available

February 21, 2021

Completed
Last Updated

June 16, 2021

Status Verified

June 1, 2021

Enrollment Period

2.1 years

First QC Date

July 9, 2010

Results QC Date

March 2, 2018

Last Update Submit

June 14, 2021

Conditions

Infertility

Keywords

Involuntary childlessnessInfertilityIVFEWICouples in IVF treatmentPsychosocial intervention

Outcome Measures

Primary Outcomes (1)

  • The Effect of Expressive Writing Intervention on Fertility Related Stress

    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.

    follow-up 2 (3 months)

Secondary Outcomes (1)

  • Pregnancy Rate

    measured at follow-up (t3) 3 months

Study Arms (2)

counselling

EXPERIMENTAL

Does couples in IVF treatment benefit from emotional disclosure

Behavioral: Expressive writing

Control

ACTIVE COMPARATOR

Neutral writing exercise

Behavioral: Active ctrl

Interventions

Expressive writingBEHAVIORAL

3 consecutive days of writing

Also known as: EWI
counselling
Active ctrlBEHAVIORAL

Control

Control

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • heterosexual couples lesbian couples

You may not qualify if:

  • couples; where one of them suffers from a genetic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, Aarhus University

Aarhus, Jylland, 8000, Denmark

Location

Related Publications (2)

  • 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: 34949542DERIVED

  • 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.

    PMID: 28007790DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Results Point of Contact

Title
Yoon Frederiksen
Organization
Aarhus University
yoonf@psy.au.dk
+4587565871

Study Officials

  • Bobby Zachariae, prof.med.,

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD.-fellowship

Study Record Dates

First Submitted

July 9, 2010

First Posted

August 23, 2010

Study Start

November 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 16, 2021

Results First Posted

February 21, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)