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SubfertilityDOTNCT02302781

Why Subfertile Couples Drop Out

An observational study of Subfertility, run by Isala at 7 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 44 yearsHealthy volunteers can take part
Conditions the study is for
Subfertility
What is being tested?
Questionnaires
How many people
500 participants
Where
7 sitesNetherlands
Study dates
Apr 2015to 1 Aug 2023
How long will I take part?
3 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 44 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

7 sites in 1 country.

7 sites in 1 country

Netherlands7 sites

  • Noordwest Ziekenhuis Groep

    Den Helder, North Holland, 1782 GZ

  • St Antonius Hospital

    Nieuwegein, Utrecht, 3435 CM

  • Erasmus Medical Centre

    Rotterdam, South Holland, 3000 CA

  • Elisabeth Twee Stedeb Hospital

    Tilburg, North Brabant, 5022 GC

  • Maxima Medisch Centrum

    Veldhoven, North Brabant, 5504 DB

  • Reinier de Graaf Ziekenhuis Groep

    Voorburg, South Holland, 2275 CX

  • Isala

    Zwolle, Overijssel, 8000 GK

Other trials in Netherlands

About this study

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

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.

Read the 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)

Conditions
Subfertility
Being tested
Questionnaires
Keywords
Reasons for Dropout, Subfertility, IVF, NON IVF
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnairesOther

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

Study groups in NCT02302781
Study groupRoleWhat they receive
Subfertile couplesCouples 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.
Receives: Other: Questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 5 years

Secondary outcomes (4)

  1. Reasons

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

    Measured: 5 years

  2. Patient satisfaction

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

    Measured: 5 years

  3. Demographic characteristics

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

    Measured: 5 years

  4. 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).

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2014 (estimated)
  2. Study startApr 2015
  3. Primary completion1 Aug 2023
  4. Study completion1 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (actual)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02302781
Sponsor's protocol ID
NL47393.075.14
Acronym
DOT
Status last verified
Mar 2024
First submitted
25 Nov 2014
Last updated
6 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Aarts JW, van Empel IW, Boivin J, Nelen WL, Kremer JA, Verhaak CM. Relationship between quality of life and distress in infertility: a validation study of the Dutch FertiQoL. Hum Reprod. 2011 May;26(5):1112-8. doi: 10.1093/humrep/der051. Epub 2011 Mar 3.

    PubMed 21372046

  • Aarts JW, Huppelschoten AG, van Empel IW, Boivin J, Verhaak CM, Kremer JA, Nelen WL. How patient-centred care relates to patients' quality of life and distress: a study in 427 women experiencing infertility. Hum Reprod. 2012 Feb;27(2):488-95. doi: 10.1093/humrep/der386. Epub 2011 Nov 22.

    PubMed 22108249

  • Boivin J, Takefman J, Braverman A. The fertility quality of life (FertiQoL) tool: development and general psychometric properties. Hum Reprod. 2011 Aug;26(8):2084-91. doi: 10.1093/humrep/der171. Epub 2011 Jun 10.

    PubMed 21665875

  • Brandes M, van der Steen JO, Bokdam SB, Hamilton CJ, de Bruin JP, Nelen WL, Kremer JA. When and why do subfertile couples discontinue their fertility care? A longitudinal cohort study in a secondary care subfertility population. Hum Reprod. 2009 Dec;24(12):3127-35. doi: 10.1093/humrep/dep340. Epub 2009 Sep 26.

    PubMed 19783833

  • Dawson AA, Diedrich K, Felberbaum RE. Why do couples refuse or discontinue ART? Arch Gynecol Obstet. 2005 Nov;273(1):3-11. doi: 10.1007/s00404-005-0010-5. Epub 2005 Oct 28.

    PubMed 16080011

  • van Dongen AJ, Verhagen TE, Dumoulin JC, Land JA, Evers JL. Reasons for dropping out from a waiting list for in vitro fertilization. Fertil Steril. 2010 Oct;94(5):1713-6. doi: 10.1016/j.fertnstert.2009.08.066. Epub 2009 Nov 6.

    PubMed 19896662

  • van Empel IW, Aarts JW, Cohlen BJ, Huppelschoten DA, Laven JS, Nelen WL, Kremer JA. Measuring patient-centredness, the neglected outcome in fertility care: a random multicentre validation study. Hum Reprod. 2010 Oct;25(10):2516-26. doi: 10.1093/humrep/deq219. Epub 2010 Aug 18.

    PubMed 20719811

  • Gameiro S, Boivin J, Peronace L, Verhaak CM. Why do patients discontinue fertility treatment? A systematic review of reasons and predictors of discontinuation in fertility treatment. Hum Reprod Update. 2012 Nov-Dec;18(6):652-69. doi: 10.1093/humupd/dms031. Epub 2012 Aug 6.

    PubMed 22869759

  • Joseph O, Alfons V, Rob S. Further validation of the Maudsley Marital Questionnaire (MMQ). Psychol Health Med. 2007 May;12(3):346-52. doi: 10.1080/13548500600855481.

    PubMed 17510905

  • McDowell S, Murray A. Barriers to continuing in vitro fertilisation--why do patients exit fertility treatment? Aust N Z J Obstet Gynaecol. 2011 Feb;51(1):84-90. doi: 10.1111/j.1479-828X.2010.01236.x. Epub 2010 Oct 22.

    PubMed 21299515

  • Olivius C, Friden B, Borg G, Bergh C. Why do couples discontinue in vitro fertilization treatment? A cohort study. Fertil Steril. 2004 Feb;81(2):258-61. doi: 10.1016/j.fertnstert.2003.06.029.

    PubMed 14967352

  • Rajkhowa M, McConnell A, Thomas GE. Reasons for discontinuation of IVF treatment: a questionnaire study. Hum Reprod. 2006 Feb;21(2):358-63. doi: 10.1093/humrep/dei355. Epub 2005 Nov 3.

    PubMed 16269448

  • Smeenk JM, Verhaak CM, Stolwijk AM, Kremer JA, Braat DD. Reasons for dropout in an in vitro fertilization/intracytoplasmic sperm injection program. Fertil Steril. 2004 Feb;81(2):262-8. doi: 10.1016/j.fertnstert.2003.09.027.

    PubMed 14967353

  • Spinhoven P, Ormel J, Sloekers PP, Kempen GI, Speckens AE, Van Hemert AM. A validation study of the Hospital Anxiety and Depression Scale (HADS) in different groups of Dutch subjects. Psychol Med. 1997 Mar;27(2):363-70. doi: 10.1017/s0033291796004382.

    PubMed 9089829

  • Van den Broeck U, Holvoet L, Enzlin P, Bakelants E, Demyttenaere K, D'Hooghe T. Reasons for dropout in infertility treatment. Gynecol Obstet Invest. 2009;68(1):58-64. doi: 10.1159/000214839. Epub 2009 Apr 25.

    PubMed 19401627

Questions about this trial

What is this clinical trial studying?

An observational study of Subfertility, run by Isala at 7 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dropout rates (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02302781, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.

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