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 |
| Secondary identifying numbers | Grant no.: 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
Scientific
Institute of Psychology
Department of Clinical Psychology and Psychotherapy
University of Bern
Gesellschaftsstrasse 49
Bern
3012
Switzerland
| hansjoerg.znoj@psy.unibe.ch |
Study information
| Study design | Interventional multicentre prospective (longitudinal) blinded randomised experimental intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/06/2007 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | A total of 120 participants |
| 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
3012
Switzerland
Sponsor information
Swiss National Science Foundation (Switzerland)
Government
Government
Wildhainweg 3
Bern
3001
Switzerland
| pri@snf.ch | |
| Website | http://www.snf.ch/D/Seiten/default.aspx |
"ROR" |
https://ror.org/00yjd3n13 |
Funders
Funder type
Government
Swiss National Science Foundation (Switzerland) (grant ref: 325100-11375411)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Schweizerischer Nationalfonds, Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerische Nationalfonds, SNF, SNSF, FNS
- Location
- Switzerland
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
