Trial document




drksid header

  DRKS00018378

Trial Description

start of 1:1-Block title

Title

Follow-up survey infertility treatment - five years later

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

NAKIWU

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

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

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00018378
  •   2019/11/13
  •   [---]*
  •   yes
  •   Approved
  •   S-744/2019, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   N97 -  Female infertility
  •   N46 -  Male infertility
end of 1:N-Block indications
start of 1:N-Block interventions

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.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

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.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2020/01/11
  •   296
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

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.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

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-sponsor
    start of 1:1-Block address contact primary-sponsor
    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-contact
    start of 1:1-Block address contact scientific-contact
    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-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

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 materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.