Why Subfertile Couples Drop Out

NCT02302781 | Completed DMC

• 1 other identifier: NL47393.075.14
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 7

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.

Conditions

Subfertility

Keywords

Reasons for Dropout; Subfertility; IVF; NON IVF

Outcome Measures

Primary Outcomes (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).

  5 years

Secondary Outcomes (4)

• Reasons

  5 years

• Patient satisfaction

  5 years

• Demographic characteristics

  5 years

• Predictors

  5 years

Study Arms (1)

Subfertile couples

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

Interventions

Questionnaires OTHER

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

Subfertile couples

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Unable to read or speak the Dutch language
• Medical contra-indication for pregnancy
• Previous OFO (initial infertility consultation), non IVF or IVF/ICSI cycles

Sponsors & Collaborators

• Isala: lead
• Erasmus Medical Center: collaborator
• Elisabeth-TweeSteden Ziekenhuis: collaborator
• Reinier de Graaf Groep: collaborator
• St. Antonius Hospital: collaborator
• Maxima Medical Center: collaborator
• Noordwest Ziekenhuisgroep: collaborator

Study Sites (7)

Elisabeth Twee Stedeb Hospital

Tilburg, North Brabant, 5022 GC, Netherlands

Location

Maxima Medisch Centrum

Veldhoven, North Brabant, 5504 DB, Netherlands

Location

Noordwest Ziekenhuis Groep

Den Helder, North Holland, 1782 GZ, Netherlands

Location

Isala

Zwolle, Overijssel, 8000 GK, Netherlands

Location

Erasmus Medical Centre

Rotterdam, South Holland, 3000 CA, Netherlands

Location

Reinier de Graaf Ziekenhuis Groep

Voorburg, South Holland, 2275 CX, Netherlands

Location

St Antonius Hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

Related Publications (22)

• 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.

  PMID: 21372046 BACKGROUND

• 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.

  PMID: 22108249 BACKGROUND

• 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.

  PMID: 21665875 BACKGROUND

• 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.

  PMID: 19783833 BACKGROUND

• 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.

  PMID: 16080011 BACKGROUND

• 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.

  PMID: 19896662 BACKGROUND

• 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.

  PMID: 20719811 BACKGROUND

• 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.

  PMID: 22869759 BACKGROUND

• 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.

  PMID: 17510905 BACKGROUND

• 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.

  PMID: 21299515 BACKGROUND

• 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.

  PMID: 14967352 BACKGROUND

• 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.

  PMID: 16269448 BACKGROUND

• 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.

  PMID: 14967353 BACKGROUND

• 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.

  PMID: 9089829 BACKGROUND

• 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.

  PMID: 19401627 BACKGROUND

• Verberg MF, Eijkemans MJ, Heijnen EM, Broekmans FJ, de Klerk C, Fauser BC, Macklon NS. Why do couples drop-out from IVF treatment? A prospective cohort study. Hum Reprod. 2008 Sep;23(9):2050-5. doi: 10.1093/humrep/den219. Epub 2008 Jun 10.

  PMID: 18544578 BACKGROUND

• Verhaak CM, Lintsen AM, Evers AW, Braat DD. Who is at risk of emotional problems and how do you know? Screening of women going for IVF treatment. Hum Reprod. 2010 May;25(5):1234-40. doi: 10.1093/humrep/deq054. Epub 2010 Mar 13.

  PMID: 20228392 BACKGROUND

• Boivin J, Domar AD, Shapiro DB, Wischmann TH, Fauser BC, Verhaak C. Tackling burden in ART: an integrated approach for medical staff. Hum Reprod. 2012 Apr;27(4):941-50. doi: 10.1093/humrep/der467. Epub 2012 Jan 18.

  PMID: 22258661 BACKGROUND

• Boivin J, Griffiths E, Venetis CA. Emotional distress in infertile women and failure of assisted reproductive technologies: meta-analysis of prospective psychosocial studies. BMJ. 2011 Feb 23;342:d223. doi: 10.1136/bmj.d223.

  PMID: 21345903 BACKGROUND

• Boivin J, Lancastle D. Medical waiting periods: imminence, emotions and coping. Womens Health (Lond). 2010 Jan;6(1):59-69. doi: 10.2217/whe.09.79.

  PMID: 20088730 BACKGROUND

• Sharma V, Allgar V, Rajkhowa M. Factors influencing the cumulative conception rate and discontinuation of in vitro fertilization treatment for infertility. Fertil Steril. 2002 Jul;78(1):40-6. doi: 10.1016/s0015-0282(02)03160-6.

  PMID: 12095488 BACKGROUND

• Verhaak CM, Smeenk JM, Evers AW, Kremer JA, Kraaimaat FW, Braat DD. Women's emotional adjustment to IVF: a systematic review of 25 years of research. Hum Reprod Update. 2007 Jan-Feb;13(1):27-36. doi: 10.1093/humupd/dml040. Epub 2006 Aug 29.

  PMID: 16940360 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• B.J. Cohlen, MD/PhD

  Isala Zwolle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. B.J. Cohlen, Fertility Centre Isala

Study Record Dates

• First Submitted: November 25, 2014
• First Posted: November 27, 2014
• Study Start: April 1, 2015
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

NL (7)