Why Subfertile Couples Drop Out

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

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

Conditions
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Subfertility

Intervention / Treatment
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* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subfertile couples<br>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<br>* Several validated questionnaires, depending on moment in fertility work up or treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dropout rates | 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 | Investigate the reasons for dropout, using the 'reason for dropout' questionnaire (made by the researchteam). | 5 years | 
| Patient satisfaction | Examine patient satisfaction with received fertility care, using the 'patient centredness questionnaire infertility' (PCQ-infertility). | 5 years | 
| Demographic characteristics | Identify demographic characteristics of dropout patients, using the 'demographic questions' (made by the researchteam). | 5 years | 
| Predictors | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reasons for Dropout, Subfertility, IVF, NON IVF