|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
German Clinical Trials Register |
|
Last refreshed on:
|
8 April 2024 |
|
Main ID: |
DRKS00014260 |
|
Date of registration:
|
22/03/2018 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Psychological protective and risk factors in infertile women and men before assisted reproductive treatment - a multicentre study in Germany, Austria and Switzerland
|
|
Scientific title:
|
Psychological protective and risk factors in infertile women and men before assisted reproductive treatment - a multicentre study in Germany, Austria and Switzerland - D_A_CH study |
|
Date of first enrolment:
|
01/05/2018 |
|
Target sample size:
|
1000 |
|
Recruitment status: |
Complete |
|
URL:
|
http://drks.de/search/en/trial/DRKS00014260 |
|
Study type:
|
observational |
|
Study design:
|
Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: screening
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Austria
|
Germany
|
Switzerland
| | | | | |
|
Contacts
|
|
Name:
|
Tewes
Wischmann |
|
Address:
|
Bergheimer Str. 20
69115
Heidelberg
Germany |
|
Telephone:
|
+49-(0)6221-568137 |
|
Email:
|
tewes.wischmann@med.uni-heidelberg.de |
|
Affiliation:
|
Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg |
|
|
Name:
|
Tewes
Wischmann |
|
Address:
|
Bergheimer Str. 20
69115
Heidelberg
Germany |
|
Telephone:
|
+49-(0)6221-568137 |
|
Email:
|
tewes.wischmann@med.uni-heidelberg.de |
|
Affiliation:
|
Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: All couples undergoing assisted reproductive treatment in one of the five centers included in the study, who agreed to participate and who have sufficient knowledge of the German language. Only one of the two partners of a couple may also participate. The participants have to be at least 18 years old. Participants have to be competent persons.
Exclusion criteria: Exclusion criteria are persons not willing to participate, with insufficient knowledge of German or study drop-outs.
Age minimum:
18 Years
Age maximum:
None
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Male infertility
|
|
Female infertility
|
N97
N46
|
|
Intervention(s)
|
|
Group 1: Assessment of women and men before infertility treatment with questionnaires on self-efficacy (measured with the infertility self-efficacy scale ISE) and on psychosocial risk factors as anxiety, depression, missing social support and negative cognitions (measured with the ScreenIVF), then analysed with the Actor-Partner-Interdependence-Model.
|
|
Primary Outcome(s)
|
|
Questionnaires on sociodemographic data (Soziodat), self-efficacy (Infertility Self-Efficacy Scale), and screening for psychological risk factors (ScreenIVF) of women and men with first contact in an fertility center.
|
|
Source(s) of Monetary Support
|
|
Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
|
|
Ethics review
|
Status: Approved
Approval date: 16/03/2018
Contact:
ethikkommission-I@med.uni-heidelberg.de
Ethikkommission der Medizinischen Fakultät Heidelberg
+49-6221-338220
ethikkommission-I@med.uni-heidelberg.de
|
|