Impact of a psychological intervention in patients under assisted reproductive treatment (in vitro fertilisation [IVF]/intra-cytoplasmic sperm injection [ICSI])

ISRCTN	ISRCTN68794421
DOI	https://doi.org/10.1186/ISRCTN68794421
Protocol serial number	Grant no.: 325100-11375411
Sponsor	Swiss National Science Foundation (Switzerland)
Funder	Swiss National Science Foundation (Switzerland) (grant ref: 325100-11375411)

Submission date: 11/03/2009
Registration date: 11/05/2009
Last edited: 11/05/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Hansjörg Znoj
Scientific

Institute of Psychology
Department of Clinical Psychology and Psychotherapy
University of Bern
Gesellschaftsstrasse 49
Bern
3012
Switzerland

Email	hansjoerg.znoj@psy.unibe.ch

Study information

Primary study design	Interventional
Study design	Interventional multicentre prospective (longitudinal) blinded randomised experimental intervention study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	Cantonal Ethics Committee of Bern (Switzerland) gave approval on the 22nd March 2007 (ref: KEK-BE 005/07)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	120
Key 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)
Key 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
Date of first enrolment	01/06/2007
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Switzerland

Study participating centre

Institute of Psychology

Bern
3012
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes