Condition category
Urological and Genital Diseases
Date applied
11/03/2009
Date assigned
11/05/2009
Last edited
11/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.snf.ch/D/Seiten/default.aspx

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

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

Publication citations

Additional files

Editorial Notes