| - candidate number | 1154 |
| - NTR Number | NTR84 |
| - ISRCTN | ISRCTN76355836 |
| - Date ISRCTN created | 12-sep-2005 |
| - date ISRCTN requested | 15-aug-2005 |
| - Date Registered NTR | 15-aug-2005 |
| - Secondary IDs | ZON-MW 945-03-013 |
| - Public Title | Preimplantation genetic screening (PGS) for aneuploidies in patients with advanced maternal age undergoing in vitro fertilization. |
| - Scientific Title | Preimplantation genetic screening (PGS) for aneuploidies in patients with advanced maternal age undergoing in vitro fertilization. |
| - ACRONYM | N/A |
| - hypothesis | To 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) studied | Subfertility, Infertility |
| - Inclusion criteria | Women between 35 and 41 years of age, undergoing IVF (in vitro fertilization) or ICSI (intracytoplasmatic sperm injection). |
| - Exclusion criteria | N/A |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | Triple |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-mei-2003 |
| - planned closingdate | 1-mei-2006 |
| - Target number of participants | 372 |
| - Interventions | 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). A maximum of two embryos will be transferred, according to the ESHRE-guidelines. In both treatment arms three treatment-cycles will be offered. |
| - Primary outcome | Ongoing pregnancy rate. |
| - Secondary outcome | Time to pregnancy, clinical pregnancy rate, pregnancy outcome, implantation rate. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | Dr. Sebastiaan Mastenbroek |
| - CONTACT for SCIENTIFIC QUERIES | MD. PhD. Fulco Veen, van der |
| - Sponsor/Initiator | Academic Medical Center (AMC) |
| - Funding (Source(s) of Monetary or Material Support) | ZON-MW, The Netherlands Organization for Health Research and Development |
| - Publications | N Engl J Med. 2007 Jul 5;357(1):9-17. Epub 2007 Jul 4. |
| - Brief summary | A 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) | |
| - RECORD | 28-jul-2005 - 11-nov-2008 |
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