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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN68794421

Enrollment

120

Registered

2009-05-11

Start date

2007-06-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility Urological and Genital Diseases Female infertility

Interventions

Psychological intervention versus a waiting control group. Psychological intervention (fertility group intervention): A combination of clarification and mastery techniques, based primarily on princi

Eligibility

Sex/Gender

Female

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026