Follow-up survey infertility treatment - five years later
Organizational Data
- DRKS-ID:
- DRKS00018378
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2019-11-13
- Last update in DRKS:
- 2020-05-19
- Registration type:
- Prospective
Acronym/abbreviation of the study
NAKIWU
URL of the study
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.
Health condition or problem studied
- ICD10:
- N97 - Female infertility
- ICD10:
- N46 - Male infertility
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- All 296 persons who took part in the first project 2014/15 will be examined after five years by means of a postal questionnaire.
Endpoints
- 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.
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Institut für Medizinische Psychologie Heidelberg
Recruitment period and number of participants
- Planned study start date:
- 2019-12-01
- Actual study start date:
- 2020-01-11
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 296
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 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
Primary Sponsor
- Address:
- Institut für Medizinische Psychologie, Universitätsklinikum HeidelbergProf. Dr. Dipl.-Psych. Tewes WischmannBergheimer Str. 2069115 HeidelbergGermany
- Telephone:
- +49-(0)6221-568137
- Fax:
- +49-(0)6221-565303
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medpsych.uni-hd.de/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Institut für Medizinische Psychologie, Universitätsklinikum HeidelbergProf. Dr. Dipl.-Psych. Tewes WischmannBergheimer Str. 2069115 HeidelbergGermany
- Telephone:
- +49-(0)6221-568137
- Fax:
- +49-(0)6221-565303
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medpsych.uni-hd.de/
Contact for Public Queries
- Address:
- Institut für Medizinische Psychologie, Universitätsklinikum HeidelbergProf. Dr. Dipl.-Psych. Tewes WischmannBergheimer Str. 2069115 HeidelbergGermany
- Telephone:
- +49-(0)6221-568137
- Fax:
- +49-(0)6221-565303
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medpsych.uni-hd.de/
Principal Investigator
- Address:
- Institut für Medizinische Psychologie, Universitätsklinikum HeidelbergProf. Dr. Dipl.-Psych. Tewes WischmannBergheimer Str. 2069115 HeidelbergGermany
- Telephone:
- +49-(0)6221-568137
- Fax:
- +49-(0)6221-565303
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medpsych.uni-hd.de/
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Institut für Medizinische Psychologie, Universitätsklinikum HeidelbergBergheimer Str. 2069115 HeidelbergGermany
- Telephone:
- +49-(0)6221-568137
- Fax:
- +49-(0)6221-565303
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medpsych.uni-hd.de/
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Fakultät HeidelbergAlte Glockengießerei 11/169115 HeidelbergGermany
- Telephone:
- +49-6221-338220
- Fax:
- +49-6221-3382222
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2019-10-17
- Ethics committee number:
- S-744/2019
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2019-11-11
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry