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ISRCTN
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ISRCTN76355836
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ClinicalTrials.gov identifier
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Public title
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Preimplantation genetic screening for aneuploidies in patients with advanced maternal age undergoing in vitro fertilisation
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Scientific title
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Acronym
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N/A
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Serial number at source
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ZonMw: 945-03-013; NTR84
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Study hypothesis
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To determine whether in vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI) combined with preimplantation genetic screening (PGS) in patients with advanced maternal age, i.e. women between 35 and 41 years of age, is a cost-effective alternative compared to IVF/ICSI without PGS.
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Lay summary
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Ethics approval
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Received from the local medical ethics committee
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Study design
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Randomised, active controlled, parallel group, double blinded, multicentre trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Subfertility, infertility
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Participants - inclusion criteria
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1. Women between 35 and 41 years of age
2. Undergoing IVF or ICSI
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Participants - exclusion criteria
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Does not comply with the above inclusion criteria
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Anticipated start date
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01/05/2003
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Anticipated end date
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01/05/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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372
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Interventions
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Patients are allocated at random to one of two treatment arms:
1. IVF/ICSI with PGS (selection of embryos based on normal number of studied chromosomes), or
2. IVF/ICSI without PGS (selection of embryos based on morphology).
A maximum of two embryos will be transferred, according to the European Society of Human Reproduction and Embryology (ESHRE)-guidelines. In both treatment arms three treatment-cycles will be offered.
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Primary outcome measure(s)
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Ongoing pregnancy rate.
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Secondary outcome measure(s)
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1. Time to pregnancy
2. Clinical pregnancy rate
3. Pregnancy outcome
4. Implantation rate
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Sources of funding
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The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/17611204
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Contact name
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Dr
Sebastiaan
Mastenbroek
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Address
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Center For Reproductive Medicine
Academic Medical Center
Meibergdreef 9 (A1-229)
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City/town
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Amsterdam
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Zip/Postcode
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1105 AZ
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Country
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Netherlands
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Tel
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+31 (0)20 566 7524/3090
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Fax
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+31 (0)20 566 9206
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Email
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S.Mastenbroek@amc.uva.nl
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Sponsor
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Academic Medical Center (AMC) (The Netherlands)
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Address
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Postbus 22660
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City/town
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Amsterdam
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Zip/Postcode
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1100 DD
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Country
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Netherlands
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Sponsor website:
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http://www.amc.uva.nl/
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Date applied
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12/09/2005
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Last edited
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20/10/2008
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Date ISRCTN assigned
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12/09/2005
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