Contact information
Type
Scientific
Primary contact
Prof Hansjörg Znoj
ORCID ID
Contact details
Institute of Psychology
Department of Clinical Psychology and Psychotherapy
University of Bern
Gesellschaftsstrasse 49
Bern
3012
Switzerland
hansjoerg.znoj@psy.unibe.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Grant no.: 325100-11375411
Study information
Scientific title
Impact of a psychological intervention in patients under assisted reproductive treatment (in vitro fertilisation [IVF]/intra-cytoplasmic sperm injection [ICSI]): a prospective (longitudinal) blinded randomised experimental intervention study
Acronym
Study hypothesis
1. A significant difference in psychological outcome is expected between groups. Specifically, it is assumed that the group with the psychological intervention will have better outcomes in terms of psychological functioning (quality of life and depression, suffering from infertility).
2. A difference in biomedical outcome is expected between groups. As above, it is assumed that the group in the psychological intervention condition will profit in terms of a higher chance of pregnancy.
Ethics approval
Cantonal Ethics Committee of Bern (Switzerland) gave approval on the 22nd March 2007 (ref: KEK-BE 005/07)
Study design
Interventional multicentre prospective (longitudinal) blinded randomised experimental intervention study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Infertility
Intervention
Psychological intervention versus a waiting control group.
Psychological intervention (fertility group intervention):
A combination of clarification and mastery techniques, based primarily on principles of cognitive behavioural therapy, clarification-oriented therapy and system therapy. The intervention consists of 10 weekly sessions organised according to 10 thematic blocks: a structured group/couple setting and a combination of educational and supportive therapeutic elements.
Waiting control group:
The control group is randomised to the waiting list control patients for 6 months. After this time they could participate in the intervention if they want.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Specific stress reactions:
1.1. Infertility distress questionnaire (Fragebogen zur infertilitätsbedingten Belastung [IBS]; 11 items)
1.2. Cognitions in infertility questionnaire (Kognitionen bei Infertilität [KINT]); 20 items)
2. Psychological functioning:
2.1. Centre for Epidemiologic Studies Depression Scale (CES-D); 20 items
2.2. German Inkongruenzfragebogen (K-INK); 23 items
3. Pregnancy rate
All primary and secondary outcome measures were assessed at baseline, after 5 weeks, at post-treatment (12 weeks after baseline), and at six-month follow-up.
Secondary outcome measures
1. Psychosocial conditions:
1.1. Demographic questionnaire (Socioeconomic Status [SES]; 14 items)
1.2. Relationship Assessment Scale (RAS); 7 items
1.3. Sozialer Support; 7 items
2. Coping, self-efficacy, emotion regulation:
2.1. Coping Inventory for Stressful Situations (CISS) short version; 19 items
2.2. Self-efficacy questionnaire (Selbstwirksamkeit [SWE]; 10 items)
2.3. Emotion Regulation (EMOREG); 26 items
All primary and secondary outcome measures were assessed at baseline, after 5 weeks, at post-treatment (12 weeks after baseline), and at six-month follow-up.
Overall trial start date
01/06/2007
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Written consent for this study as well as for the IVF/ICSI treatment are on hand
2. The patient is currently not in psychological treatment
3. The patient has an indication to an IVF/ICSI treatment
4. The patient is in reproductive age (maximal age is 42 years)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
A total of 120 participants
Participant exclusion criteria
1. Inability to communicate
2. Fundamental contraindications to an IVF/ICSI treatment:
2.1. Acute/chronic infectious diseases: human immunodeficiency virus (HIV), hepatitis B, hepatitis C, syphilis
2.2. Severe psychiatric diseases: schizophrenia, severe depressive disorders
2.3. Acute/chronic addiction
2.4. Carrier of a severe genetic disease
2.5. Age of the female patient is greater than 42 years
3. Need of psychological or psychiatric treatment before or during the study
4. Not any more willing to participate in the study
5. Severe injuries to the protocol
6. Separation of the couple
7. Severe disease of one partner
Recruitment start date
01/06/2007
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Switzerland
Trial participating centre
Institute of Psychology
Bern
3012
Switzerland
Sponsor information
Organisation
Swiss National Science Foundation (Switzerland)
Sponsor details
Wildhainweg 3
Bern
3001
Switzerland
pri@snf.ch
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Swiss National Science Foundation (Switzerland) (grant ref: 325100-11375411)
Alternative name(s)
Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNF, SNSF, FNS
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Switzerland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary