Why Subfertile Couples Drop Out (DOT)

March 5, 2024 updated by: B.J. Cohlen, Isala

Why Subfertile Couples Drop Out (Drop Out Trial); a Prospective Survey in the Netherlands.

Dropout rates for fertility treatments are high. This study will examine the rate of patients that drop out during any type of subfertility work up or treatment. Furthermore, we will determine what reasons for discontinuation are and we will identify the demographic characteristics of the couples and the prognostic factors for drop out during assessment or treatment at a Fertility Centre in the Isala (Zwolle), Erasmus University Centre (Rotterdam), Elisabeth Twee Steden Hospital (Tilburg), Reinier de Graaf Group (Voorburg), St Antonius Hospital (Nieuwegein), Maxima Medical Centre (Veldhoven) and Noordwest Hospital Group (Den Helder/Alkmaar) in The Netherlands.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rationale Although fertility success rates are rising due to improved techniques and patients are usually highly motivated at their first visit of the clinic, dropout rates are high. Research has shown that fertility treatment is a cause for physical, psychological and economic burden.

Objective The aim of this study is to examine the rate of patient drop out during any type of subfertility work up or treatment. Furthermore, the investigators want to determine what the reasons for discontinuation are and to identify the demographic characteristics of these couples and the prognostic factors for drop out during assessment or treatment at a fertility clinic.

Study design Prospective cohort study at the fertility centres of Isala (Zwolle - The Netherlands), Erasmus University Centre (Rotterdam- The Netherlands), Elisabeth Twee Steden Hospital (Tilburg - The Netherlands), Reinier de Graaf Group (Voorburg - The Netherlands), St Antonius Hospital (Nieuwegein - The Netherlands), Maxima Medical Centre (Veldhoven - The Netherlands) and Noordwest Hospital Group (Den Helder/Alkmaar - The Netherlands).

Study population Every couple that undergoes any type of work up or treatment for subfertility problems and that has not visited any other clinic yet.

Methods Patient records of included couples will be studied and included patients will be asked to fill in a validated questionnaire after evaluations during work up or treatment. The data from both will be put in a database and analysed.

First visit (Q1) EPQ-RSS, SCREENIVF, MMQ, FertiQoL, demographic questions (128 items)

Evaluation (Q2) FertiQoL, HADS (48 items)

Evaluation (Q3) >4-6 cycles non-IVF (Q3) FertiQoL, HADS (48 items)

Evaluation (Q4) > 3 cycles IVF (Q4) FertiQoL, HADS (48 items)

Dropout (Q5) FertiQol, SCREENIVF, MMQ, PCQ-infertility, reasons for dropout (128 items)

Pregnancy (Q6) PCQ-infertility (53 items)

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Noord Brabant
      • Veldhoven, Noord Brabant, Netherlands, 5504 DB
        • Maxima Medisch Centrum
    • Noord Holland
      • Den Helder, Noord Holland, Netherlands, 1782 GZ
        • Noordwest Ziekenhuis Groep
    • Noord-Brabant
      • Tilburg, Noord-Brabant, Netherlands, 5022 GC
        • Elisabeth Twee Stedeb Hospital
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8000 GK
        • Isala
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands, 3435 CM
        • St Antonius hospital
    • Zuid Holland
      • Voorburg, Zuid Holland, Netherlands, 2275 CX
        • Reinier de Graaf Ziekenhuis Groep
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3000 CA
        • Erasmus Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 42 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Couples referred to one of the four participating hospitals with any type of subfertility for work up and/ or treatment will be screened for inclusion. Couples have not visited any other clinic yet.

Description

Inclusion Criteria:

  • Couples with any type of subfertility referred to one of the four participating centres
  • Both partners are willing and able to separately fill out the questionnaires.

Exclusion Criteria:

  • Unable to read or speak the Dutch language
  • Medical contra-indication for pregnancy
  • Previous OFO (initial infertility consultation), non IVF or IVF/ICSI cycles

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subfertile couples
Couples referred to one of the four participating hospitals with any type of subfertility for work up and/ or treatment will be screened for inclusion. Couples have not visited only other clinic yet.
Other: Questionnaires
Several validated questionnaires, depending on moment in fertility work up or treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dropout rates
Time Frame: 5 years
To identify dropout rates at all stages of fertility care at the fertility centres of Isala (Zwolle), Erasmus MC (Rotterdam), IVF centre Voorburg (Voorburg), st Elisabeth (Tilburg).
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reasons
Time Frame: 5 years
Investigate the reasons for dropout, using the 'reason for dropout' questionnaire (made by the researchteam).
5 years
Patient satisfaction
Time Frame: 5 years
Examine patient satisfaction with received fertility care, using the 'patient centredness questionnaire infertility' (PCQ-infertility).
5 years
Demographic characteristics
Time Frame: 5 years
Identify demographic characteristics of dropout patients, using the 'demographic questions' (made by the researchteam).
5 years
Predictors
Time Frame: 5 years
Identify predictors for discontinuation, using the 'Eysenck personality questionnaire' (short version or EPQ-RSS), the 'SCREENIVF' (including 'Hospital anxiety and depression scale' or HADS) questionnaire, the 'fertility quality of life questionnaire' (FertiQol) and the 'Maudsley Marital Questionnaire' (MMQ).
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isala

Collaborators

Erasmus Medical Center
St. Antonius Hospital
Noordwest Ziekenhuisgroep
Maxima Medical Center
Elisabeth-TweeSteden Ziekenhuis
Reinier de Graaf Groep

Investigators

  • Principal Investigator: B.J. Cohlen, MD/PhD, Isala Zwolle

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

November 25, 2014

First Posted (Estimated)

November 27, 2014

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL47393.075.14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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