Trial document



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  DRKS00018378

Trial Description

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Title

Follow-up survey infertility treatment - five years later

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Trial Acronym

NAKIWU

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URL of the Trial

https://www.klinikum.uni-heidelberg.de/zentrum-fuer-psychosoziale-medizin-zpm/institut-fuer-medizinische-psychologie/forschung/gynaekologische-psychologie/

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Brief Summary in Lay Language

Between July 2014 and July 2015, 150 women and 146 men with fertility disorders were examined at the University Women's Hospital Heidelberg with psychological questionnaires on risk factors (such as anxiety and depression) and coping strategies (Volmer, Rösner et al. 2017). All 296 persons who took part in the first project will be examined by postal questionnaire after five years.

A psychological questionnaire will be applied. This questionnaire includes general questions on how the topic is dealt with in each case, in particular on reasons for premature termination of fertility treatment and on the current burden caused by the unfulfilled desire for a child (in the case of couples without children) as well as (in the case of parents) on children born in the meantime and their history (e.g. spontaneous conception, reproductive medicine in Germany or abroad, foster care or adoption).

The main aim of this study is to identify psychological and medical protective and risk factors in couples who wish to have children and who have unsuccessfully completed fertility treatment (without childbirth) or who have completed treatment prematurely (drop-outs) five years after commencing fertility therapy. A secondary objective is to record possible psychological and medical predictors for pregnancy/child birth within five years of the start of infertility treatment. A further secondary objective is to investigate the absolute and relative stability of the coping strategies collected five years before in unvoluntary childless couples.

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Brief Summary in Scientific Language

5-year catamnesis after first contact in fertility clinic. Assessment of psychosocial and medical protective and risk factors in the event of unsuccessful reproductive medicine treatment or treatment drop-out, as well as assessment of the current status with regard to family formation.

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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

  •   DRKS00018378
  •   2019/11/13
  •   [---]*
  •   yes
  •   Approved
  •   S-744/2019, 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

  •   All 296 persons who took part in the first project 2014/15 will be examined after five years by means of a postal questionnaire.
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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

Identification of psychological and medical protective and risk factors in infertile couples with unsuccessfully completed fertility treatment (without child birth) or with premature discontinuation of treatment ("drop-outs") five years after the beginning of fertility therapy.

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Secondary Outcome

A secondary objective is to record possible psychological predictors for pregnancy/child birth within five years of the start of treatment.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/01/11
  •   296
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

All study participants of the first project 2014/15 who have agreed to participate in this follow-up examination and have sufficient knowledge of German.
If the partner refuses to participate, the patient can also participate as an individual (and vice versa).
Only adult women and men are included in the study.
A further inclusion criterion is the ability of the subjects to give their informed consent.

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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 ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.