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Completed

NCT Number: NCT02302781

Why Subfertile Couples Drop Out

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.

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Key information

Conditions

Subfertility Genital Diseases Infertility Urogenital Diseases

Age range

18 year–44 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Elisabeth Twee Stedeb Hospital, Tilburg, North Brabant, Netherlands

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About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

Several validated questionnaires, depending on moment in fertility work up or treatment.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Reasons

    Time frame: 5 years

    Investigate the reasons for dropout, using the 'reason for dropout' questionnaire (made by the researchteam).

  2. Patient satisfaction

    Time frame: 5 years

    Examine patient satisfaction with received fertility care, using the 'patient centredness questionnaire infertility' (PCQ-infertility).

  3. Demographic characteristics

    Time frame: 5 years

    Identify demographic characteristics of dropout patients, using the 'demographic questions' (made by the researchteam).

  4. 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).

Sponsors and collaborators

Lead sponsor

Isala

Other

Collaborators

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

Registry information

Official study title

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

Acronym: DOT

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Nov 27, 2014
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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