Trial document
DRKS00018378
Trial Description
Title
Follow-up survey infertility treatment - five years later
Trial Acronym
NAKIWU
URL of the Trial
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.
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.
Do you plan to share individual participant data with other researchers?
[---]*
Description IPD sharing plan:
[---]*
Organizational Data
- DRKS00018378
- 2019/11/13
- [---]*
- yes
- Approved
- S-744/2019, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
Secondary IDs
- [---]*
Health Condition or Problem studied
- N97 - Female infertility
- N46 - Male infertility
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.
Characteristics
- Non-interventional
- Observational study
- Single arm study
- Open (masking not used)
- [---]*
- Uncontrolled/Single arm
- Other
- Single (group)
- N/A
- N/A
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.
Secondary Outcome
A secondary objective is to record possible psychological predictors for pregnancy/child birth within five years of the start of treatment.
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2020/01/11
- 296
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
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.
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 ongoing
- [---]*
Trial Publications, Results and other Documents
- [---]*