Trial document
This trial has been registered retrospectively.
DRKS00014707
Trial Description
Title
German validation of the FertiQoL
Trial Acronym
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URL of the Trial
https://www.klinikum.uni-heidelberg.de/Gynaekologische-Psychologie.139867.0.html?&L=0
Brief Summary in Lay Language
Validation of the FertiQoL in a German sample
The “FertiQoL“ questionnaire has been constructed internationally to assess the emotional, cognitive and somatic, social and relationship-relevant aspects of fertility-specific quality of life. We are validating the questionnaire in a sample of N=596 German couples/ involuntary childless women in Heidelberg (N=452 women and men), Lübeck (N=119 women) and Munich (N=25 women).
Brief Summary in Scientific Language
Validation of the original four factor structure of the FertiQoL in a German sample of women and men with fertility problems.
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00014707
- 2018/05/02
- [---]*
- yes
- Approved
- S-325/2010, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
Secondary IDs
- [---]*
Health Condition or Problem studied
- N97 - Female infertility
- N46 - Male infertility
Interventions/Observational Groups
- Assessment of women and men before infertility treatment with questionnaires on fertility specific quality of life FertiQoL (and sociodemographic data)
Characteristics
- Non-interventional
- Observational study
- Single arm study
- Open (masking not used)
- [---]*
- Uncontrolled/Single arm
- Other
- Single (group)
- N/A
- N/A
Primary Outcome
Questionnaires on fertility specific quality of life (FertiQoL) and sociodemographic data (Soziodat) of women and men with first contact in a fertility center
Secondary Outcome
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Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
- University Medical Center
- Doctor's Practice
Recruitment
- Actual
- 2011/12/01
- 596
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
Sufficient knowledge of the German language, 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.
Addresses
-
start of 1:1-Block address primary-sponsor
- Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
- Mr. Prof. Dr. Dipl.-Psych. Tewes Wischmann
- Bergheimer Str. 20
- 69115 Heidelberg
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- +49-(0)6221-568137
- +49-(0)6221-565303
- tewes.wischmann at med.uni-heidelberg.de
- http://www.medpsych.uni-hd.de/
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
- Mr. Prof. Dr. Dipl.-Psych. Tewes Wischmann
- Bergheimer Str. 20
- 69115 Heidelberg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49-(0)6221-568137
- +49-(0)6221-565303
- tewes.wischmann at med.uni-heidelberg.de
- http://www.medpsych.uni-hd.de/
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
- Mr. Prof. Dr. Dipl.-Psych. Tewes Wischmann
- Bergheimer Str. 20
- 69115 Heidelberg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49-(0)6221-568137
- +49-(0)6221-565303
- tewes.wischmann at med.uni-heidelberg.de
- http://www.medpsych.uni-hd.de/
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
- Mr. Prof. Dr. Dipl.-Psych. Tewes Wischmann
- Bergheimer Str. 20
- 69115 Heidelberg
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- +49-(0)6221-568137
- +49-(0)6221-565303
- tewes.wischmann at med.uni-heidelberg.de
- http://www.medpsych.uni-hd.de/
end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
- 2013/11/30