to study search History

Attitude towards multiple pregnancies

Organizational Data

DRKS-ID:
DRKS00029620
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2022-07-12
Last update in DRKS:
2023-03-02
Registration type:
Prospective

Acronym/abbreviation of the study

Multiples study

URL of the study

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

Brief summary in lay language

The aim of this study is to descriptively assess attitudes towards singleton vs. twin pregnancies among couples undergoing assisted reproduction in a university fertility clinic on the background of their prior information, previous treatment experience, already existing children, risk tolerance, age and educational level. Both partners will be surveyed by means of a self-administered questionnaire.

Brief summary in scientific language

About a quarter of all births after assisted reproduction (ART) in Germany are multiple births (German IVF Registry 2020). A number of risks for the pregnant woman and the (future) children are associated with multiple pregnancies and births. The aim of this study is to descriptively assess attitudes towards singleton vs. twin pregnancies and, if applicable, embryo transfer after prolonged culture (advantages and disadvantages) among couples undergoing assisted reproduction in a university fertility clinic on the background of their prior information, previous treatment experience, already existing children, willingness to take risks, age and educational level. Both partners will be surveyed by means of a self-administered questionnaire. The data collection in the form of a quantitative cross-sectional study will be carried out on all participating couples of the fertility clinic of Heidelberg University Women's Hospital who are undergoing or are about to undergo IVF or ICSI treatment.

Health condition or problem studied

ICD10:
N46 - Male infertility
ICD10:
N97 - Female infertility
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Written survey of couples in assisted reproduction in a university fertility clinic at the time before embryo transfer before the decision to transfer 1 or 2 embryo/s on possible motives for their decision.

Endpoints

Primary outcome:
The main objective is to assess motives for (potential) use of transfers of one vs. two embryos (after prolonged culture) and the subjective evaluation of the different advantages and disadvantages by couples of a fertility clinic before IVF or ICSI.
Secondary outcome:
Secondary outcome measure is to assess the influence of moderator variables on their attitudes toward singleton vs. twin pregnancies among these couples (such as their prior information, prior treatment experience, pre-existing children, risk tolerance, age, and education level).

Study Design

Purpose:
Other
Retrospective/prospective:
Prospective
Study type:
Non-interventional
Longitudinal/cross-sectional:
Cross-sectional study
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 Frauenklinik Heidelberg

Recruitment period and number of participants

Planned study start date:
2022-07-15
Actual study start date:
2022-07-18
Planned study completion date:
2023-12-31
Actual Study Completion Date:
No Entry
Target Sample Size:
200
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
45 Years
Additional Inclusion Criteria:
All couples participating in infertility treatment (IVF or ICSI) in the fertility outpatient clinic of Heidelberg University Women's Hospital who have agreed in writing to participate in the study and have sufficient knowledge of German will receive both questionnaires. If the partner refuses to participate, the patient can also participate as an individual (and vice versa). Only adult women and men will be included in the study. The upper age limit for women is 45 years. A further inclusion criterion is the ability of the subjects to give consent.

Exclusion Criteria

Exclusion criteria consist of refusal to participate and/or insufficient knowledge of German or withdrawal from the study.

Addresses

Primary Sponsor

Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
Prof. Dr. Dipl.-Psych. Tewes Wischmann
Bergheimer Str. 20
69115 Heidelberg
Germany
Telephone:
+49-(0)6221-568137
Fax:
+49-(0)6221-565303
Contact per E-Mail
URL:
http://www.medpsych.uni-hd.de/
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
Prof. Dr. Dipl.-Psych. Tewes Wischmann
Bergheimer Str. 20
69115 Heidelberg
Germany
Telephone:
+49-(0)6221-568137
Fax:
+49-(0)6221-565303
Contact per E-Mail
URL:
http://www.medpsych.uni-hd.de/

Contact for Public Queries

Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
Prof. Dr. Dipl.-Psych. Tewes Wischmann
Bergheimer Str. 20
69115 Heidelberg
Germany
Telephone:
+49-(0)6221-568137
Fax:
+49-(0)6221-565303
Contact per E-Mail
URL:
http://www.medpsych.uni-hd.de/

Principal Investigator

Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
Prof. Dr. Dipl.-Psych. Tewes Wischmann
Bergheimer Str. 20
69115 Heidelberg
Germany
Telephone:
+49-(0)6221-568137
Fax:
+49-(0)6221-565303
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)

Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
Bergheimer Str. 20
69115 Heidelberg
Germany
Telephone:
+49-(0)6221-568137
Fax:
+49-(0)6221-565303
Contact per E-Mail
URL:
http://www.medpsych.uni-hd.de/

Ethics Committee

Address Ethics Committee

Ethikkommission der Medizinischen Fakultät Heidelberg
Alte Glockengießerei 11/1
69115 Heidelberg
Germany
Telephone:
+49-6221-338220
Fax:
+49-6221-3382222
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2022-05-17
Ethics committee number:
S-360/2022
Vote of the Ethics Committee:
Approved
Date of the vote:
2022-06-09

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
Anonymized questionnaire results will be made available upon reasonable request after completion of the study. Public availability of data not covered by ethics vote.

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:
Anfang 2024
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