Why Subfertile Couples Drop Out (DOT)

Isala

Status: Completed

Conditions: Subfertility

Treatments: Other: Questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT02302781

NL47393.075.14

Details and patient eligibility

About

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.

Full 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)

Enrollment: 500 patients

Sex: All

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Subfertile couples

Description:

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.

Treatment:

Other: Questionnaires