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Preimplantation genetic screening (PGS) for aneuploidies in patients with advanced maternal age undergoing in vitro fertilization.


- candidate number1154
- NTR NumberNTR84
- ISRCTNISRCTN76355836
- Date ISRCTN created12-sep-2005
- date ISRCTN requested15-aug-2005
- Date Registered NTR15-aug-2005
- Secondary IDsZON-MW 945-03-013 
- Public TitlePreimplantation genetic screening (PGS) for aneuploidies in patients with advanced maternal age undergoing in vitro fertilization.
- Scientific TitlePreimplantation genetic screening (PGS) for aneuploidies in patients with advanced maternal age undergoing in vitro fertilization.
- ACRONYMN/A
- hypothesisTo determine whether IVF/ICSI combined with 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.
- Healt Condition(s) or Problem(s) studiedSubfertility, Infertility
- Inclusion criteriaWomen between 35 and 41 years of age, undergoing IVF (in vitro fertilization) or ICSI (intracytoplasmatic sperm injection).
- Exclusion criteriaN/A
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingTriple
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2003
- planned closingdate1-mei-2006
- Target number of participants372
- InterventionsPatients are allocated at random to one of two treatment arms: IVF/ICSI with PGS (selection of embryos based on normal number of studied chromosomes) or IVF/ICSI without PGS (selection of embryos based on morphology). A maximum of two embryos will be transferred, according to the ESHRE-guidelines. In both treatment arms three treatment-cycles will be offered.
- Primary outcomeOngoing pregnancy rate.
- Secondary outcomeTime to pregnancy, clinical pregnancy rate, pregnancy outcome, implantation rate.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. Sebastiaan Mastenbroek
- CONTACT for SCIENTIFIC QUERIESMD. PhD. Fulco Veen, van der
- Sponsor/Initiator Academic Medical Center (AMC, Amsterdam)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN Engl J Med. 2007 Jul 5;357(1):9-17. Epub 2007 Jul 4.
- Brief summaryA double-blind randomized controlled trial is conducted to determine whether IVF/ICSI combined with PGS in patients with advanced maternal age, i.e. women between 35 and 40 years of age, is a cost-effective alternative compared to IVF/ICSI without PGS.
Patients are allocated at random to one of two treatment arms:
IVF/ICSI with PGS (selection of embryos based on normal number of studied chromosomes)
or IVF/ICSI without PGS (selection of embryos based on morphology). Primary outcome is ongoing pregnancy. Secondary outcomes are time to pregnancy, clinical pregnancy rate, pregnancy outcome and implantation rate.
- Main changes (audit trail)
- RECORD28-jul-2005 - 11-nov-2008


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