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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN76355836 |
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Date of registration:
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12/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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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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Date of first enrolment:
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01/05/2003 |
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Target sample size:
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372 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN76355836 |
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Study type:
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Interventional |
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Study design:
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Randomised, active controlled, parallel group, double blinded, multicentre trial (Screening)
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Sebastiaan
Mastenbroek |
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Address:
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Center For Reproductive Medicine
Academic Medical Center
Meibergdreef 9 (A1-229)
1105 AZ
Amsterdam
Netherlands |
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Telephone:
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+31 (0)20 566 7524/3090 |
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Email:
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S.Mastenbroek@amc.uva.nl |
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Affiliation:
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Women between 35 and 41 years of age
2. Undergoing IVF or ICSI
Exclusion criteria: Does not comply with the above inclusion criteria
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Subfertility, infertility
Pregnancy and Childbirth
Infertility
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Intervention(s)
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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(s)
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Ongoing pregnancy rate.
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Secondary Outcome(s)
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1. Time to pregnancy
2. Clinical pregnancy rate
3. Pregnancy outcome
4. Implantation rate
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Secondary ID(s)
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ZonMw: 945-03-013; NTR84
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Source(s) of Monetary Support
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The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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