Why Subfertile Couples Drop Out

Completed

• Conditions: Subfertility
• Interventions: Other: Questionnaires

• Registration Number: NCT02302781
• Lead Sponsor: Isala

Brief Summary

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

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 Timeline

• Study First Submitted: 2014-11-25
• Study First Submitted QC: 2014-11-25
• Study First Posted: 2014-11-27
• Study Start: 2015-04
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subfertile couples	Questionnaires	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.

Primary Outcome Measures

Name	Time	Method
Dropout rates	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 Outcome Measures

Name	Time	Method
Reasons	5 years	Investigate the reasons for dropout, using the 'reason for dropout' questionnaire (made by the researchteam).
Demographic characteristics	5 years	Identify demographic characteristics of dropout patients, using the 'demographic questions' (made by the researchteam).
Predictors	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).
Patient satisfaction	5 years	Examine patient satisfaction with received fertility care, using the 'patient centredness questionnaire infertility' (PCQ-infertility).

Trial Locations

Locations (7)

St Antonius Hospital; 🇳🇱 Nieuwegein, Utrecht, Netherlands

Maxima Medisch Centrum; 🇳🇱 Veldhoven, Noord Brabant, Netherlands

Isala; 🇳🇱 Zwolle, Overijssel, Netherlands

Noordwest Ziekenhuis Groep; 🇳🇱 Den Helder, Noord Holland, Netherlands

Elisabeth Twee Stedeb Hospital; 🇳🇱 Tilburg, Noord-Brabant, Netherlands

Reinier de Graaf Ziekenhuis Groep; 🇳🇱 Voorburg, Zuid Holland, Netherlands

Erasmus Medical Centre; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands