Clinical trial NCT02302781: Why Subfertile Couples Drop Out
Official title: Why Subfertile Couples Drop Out (Drop Out Trial); a Prospective Survey in the Netherlands.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subfertility
Keywords: Reasons for Dropout
Subfertility
IVF
NON IVF
Lead sponsor: Isala
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
name: Elisabeth-TweeSteden Ziekenhuis
name: Reinier de Graaf Groep
name: St. Antonius Hospital
name: Maxima Medical Center
name: Noordwest Ziekenhuisgroep
First posted: 2014-11-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Dropout rates
timeFrame: 5 years
Secondary outcomes:
measure: Reasons
timeFrame: 5 years
measure: Patient satisfaction
timeFrame: 5 years
measure: Demographic characteristics
timeFrame: 5 years
measure: Predictors
timeFrame: 5 years
Other outcomes:
Locations:
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
state: Noord Brabant
city: Den Helder
country: Netherlands
facility: Noordwest Ziekenhuis Groep
state: Noord Holland
city: Tilburg
country: Netherlands
facility: Elisabeth Twee Stedeb Hospital
state: Noord-Brabant
city: Zwolle
country: Netherlands
facility: Isala
state: Overijssel
city: Nieuwegein
country: Netherlands
facility: St Antonius Hospital
state: Utrecht
city: Voorburg
country: Netherlands
facility: Reinier de Graaf Ziekenhuis Groep
state: Zuid Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Centre
state: Zuid-Holland
Study officials:
affiliation: Isala Zwolle
name: B.J. Cohlen, MD/PhD
role: PRINCIPAL_INVESTIGATOR
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