Study Results
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Basic Information
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COMPLETED
500 participants
OBSERVATIONAL
2015-04-30
2023-08-01
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Questionnaires
Several validated questionnaires, depending on moment in fertility work up or treatment.
Interventions
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Questionnaires
Several validated questionnaires, depending on moment in fertility work up or treatment.
Eligibility Criteria
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Inclusion Criteria
* Both partners are willing and able to separately fill out the questionnaires.
Exclusion Criteria
* Medical contra-indication for pregnancy
* Previous OFO (initial infertility consultation), non IVF or IVF/ICSI cycles
18 Years
44 Years
ALL
Yes
Sponsors
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Erasmus Medical Center
OTHER
Elisabeth-TweeSteden Ziekenhuis
OTHER
Reinier de Graaf Groep
OTHER
St. Antonius Hospital
OTHER
Maxima Medical Center
OTHER
Noordwest Ziekenhuisgroep
OTHER
Isala
OTHER
Responsible Party
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B.J. Cohlen
Dr. B.J. Cohlen, Fertility Centre Isala
Principal Investigators
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B.J. Cohlen, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Isala Zwolle
Locations
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Elisabeth Twee Stedeb Hospital
Tilburg, North Brabant, Netherlands
Maxima Medisch Centrum
Veldhoven, North Brabant, Netherlands
Noordwest Ziekenhuis Groep
Den Helder, North Holland, Netherlands
Isala
Zwolle, Overijssel, Netherlands
Erasmus Medical Centre
Rotterdam, South Holland, Netherlands
Reinier de Graaf Ziekenhuis Groep
Voorburg, South Holland, Netherlands
St Antonius Hospital
Nieuwegein, Utrecht, Netherlands
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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NL47393.075.14
Identifier Type: -
Identifier Source: org_study_id
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