Trial Outcomes & Findings for Involuntary Childlessness and Stress Management (NCT NCT01187095)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

298 participants

Primary outcome timeframe

follow-up 2 (3 months)

Results posted on

2021-06-16

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Counselling Do couples in IVF treatment benefit from emotional disclosure Expressive writing: 3 consecutive days of writing	Control Neutral writing exercise Active ctrl: Control
Overall Study STARTED	153	142
Overall Study COMPLETED	108	108
Overall Study NOT COMPLETED	45	34

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The rows indicate the age dependent on gender

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Counselling n=153 Participants Does couples in IVF treatment benefit from emotional disclosure Expressive writing: 3 consecutive days of writing	Control n=142 Participants Neutral writing exercise Active ctrl: Control	Total n=295 Participants Total of all reporting groups
Age, Continuous Women	31.9 years STANDARD_DEVIATION 4.4 • n=83 Participants • The rows indicate the age dependent on gender	32.9 years STANDARD_DEVIATION 4.8 • n=80 Participants • The rows indicate the age dependent on gender	32.3 years STANDARD_DEVIATION 4.5 • n=163 Participants • The rows indicate the age dependent on gender
Age, Continuous Partners	33.9 years STANDARD_DEVIATION 5.9 • n=70 Participants • The rows indicate the age dependent on gender	34.7 years STANDARD_DEVIATION 6.2 • n=62 Participants • The rows indicate the age dependent on gender	34.3 years STANDARD_DEVIATION 6.0 • n=132 Participants • The rows indicate the age dependent on gender
Sex: Female, Male Female	83 Participants n=153 Participants	80 Participants n=142 Participants	163 Participants n=295 Participants
Sex: Female, Male Male	70 Participants n=153 Participants	62 Participants n=142 Participants	132 Participants n=295 Participants
Region of Enrollment Denmark	153 Participants n=153 Participants	142 Participants n=142 Participants	295 Participants n=295 Participants

PRIMARY outcome

Timeframe: follow-up 2 (3 months)

Population: Couples undergoing IVF or ICSI fertility treatment

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.

Outcome measures

Outcome measures
Measure	Counselling n=153 Participants Do couples in IVF treatment benefit from emotional disclosure Expressive writing: 3 consecutive days of writing	Control n=142 Participants Neutral writing exercise Active ctrl: Control
The Effect of Expressive Writing Intervention on Fertility Related Stress Baseline	17.2 units on a scale Standard Deviation 9.0	15.7 units on a scale Standard Deviation 9.1
The Effect of Expressive Writing Intervention on Fertility Related Stress Follow up 1	17.4 units on a scale Standard Deviation 10.2	17.1 units on a scale Standard Deviation 9.8
The Effect of Expressive Writing Intervention on Fertility Related Stress Follow up 2	18.7 units on a scale Standard Deviation 9.5	17.6 units on a scale Standard Deviation 10.1

SECONDARY outcome

Timeframe: measured at follow-up (t3) 3 months

How many women achieved pregnancy in each arm

Outcome measures

Outcome measures
Measure	Counselling n=83 Participants Do couples in IVF treatment benefit from emotional disclosure Expressive writing: 3 consecutive days of writing	Control n=80 Participants Neutral writing exercise Active ctrl: Control
Pregnancy Rate	42 Participants	39 Participants

Adverse Events

Counselling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yoon Frederiksen

Aarhus University

Phone: +4587565871

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place