Trial document





This trial has been registered retrospectively.
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  DRKS00014707

Trial Description

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Title

German validation of the FertiQoL

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Trial Acronym

[---]*

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URL of the Trial

https://www.klinikum.uni-heidelberg.de/Gynaekologische-Psychologie.139867.0.html?&L=0

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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).

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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.

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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
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   N97 -  Female infertility
  •   N46 -  Male infertility
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Interventions/Observational Groups

  •   Assessment of women and men before infertility treatment with questionnaires on fertility specific quality of life FertiQoL (and sociodemographic data)
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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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

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2011/12/01
  •   596
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Sufficient knowledge of the German language, Participants have to be competent persons

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Exclusion Criteria

Exclusion criteria are persons not willing to participate, with insufficient knowledge of German or study drop- outs.

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Addresses

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    • Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr. Dipl.-Psych.  Tewes  Wischmann 
    • Bergheimer Str. 20
    • 69115  Heidelberg
    • Germany
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    • Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr. Dipl.-Psych.  Tewes  Wischmann 
    • Bergheimer Str. 20
    • 69115  Heidelberg
    • Germany
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    • Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr. Dipl.-Psych.  Tewes  Wischmann 
    • Bergheimer Str. 20
    • 69115  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr. Dipl.-Psych.  Tewes  Wischmann 
    • Bergheimer Str. 20
    • 69115  Heidelberg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/11/30
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* This entry means the parameter is not applicable or has not been set.