|- candidate number||3463|
|- NTR Number||NTR1347|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-jun-2008|
|- Secondary IDs||5 UZ Brussel|
|- Public Title||Among IVF-ICSI patients with poor implantation, does PGS increase pregnancy rates and live birth rates?|
|- Scientific Title||Among IVF-ICSI patients with poor implantation, does PGS increase pregnancy rates and live birth rates?|
|- ACRONYM||PGS, recurrent implantation failure|
|- hypothesis||The hypothesis of the present study tries to elucidate the causes of multiple IVF failures in subfertile couples with repeated implantation failure.Therefore, these couples will undergo an IVF-cycle with or without PGS.|
|- Healt Condition(s) or Problem(s) studied||Pregnancy, In vitro fertilization (IVF), Intracytoplasmic sperm injection (ICSI), Preimplantation genetic screening (PGS), Embryo implantation|
|- Inclusion criteria||1. Subfertility with need for ART with motile sperm |
2. Three or more failed IVF or ICSI attempts with embryos of good morphological quality
3. Maternal age less than 38 years
4. A normal karyotype in both partners.
|- Exclusion criteria||1. Maternal age above 38 years. |
2. Presence of uterine pathology
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2001|
|- planned closingdate||31-dec-2008|
|- Target number of participants||200|
|- Interventions||In both groups, patients underwent controlled ovarian hyperstimulation. IVF-ICSI was perfomed in every study patient. On day three of the embryonic development, preimplantation genetic diagnosis was performed on the embryos in the study group. The embryo transfer took place on day 5 of embryonic development. |
|- Primary outcome||The primary outcome is the implantation rate, which is defined as the ratio between the number of gestational sacs with a fetal heartbeat and the total number of embryos transferred.|
|- Secondary outcome||Secondary endpoints are embryo morphology and chromosomal status, number of transferred embryos and clinical pregnancy rate.
|- Timepoints||Day of egg retrieval (ovum pick-up) (t=0) |
Day of fertilisation (t=1)
Embryonic development and biopsy (t=3)
Day of embryo transfer (t=5)
Pregnancy outcome (t=35)
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Dr. Christophe Blockeel|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Christophe Blockeel|
|- Sponsor/Initiator ||Universitair Ziekenhuis Brussel (UZB), Centre for Reproductive Medicine|
(Source(s) of Monetary or Material Support)
|Universitair Ziekenhuis Brussel (UZB), Centre for Reproductive Medicine|
|- Brief summary||Objective: To verify whether advantages con derive from the implementation of preimplantation genetic diagnosis for aneuploidy in patients with recurrent failed implantation, compared with conventional treatment procedures.
Design: A randomized, controlled trial.
Setting: Centre for Reproductive Medicine of the Universitair Ziekenhuis Brussel, Brussel, Belgium.
Patient(s): Two hundred patients with recurrent failed implantation were randomized into two groups. A total of 139 patients underwent ovarian stimulation, and preimplantation genetic screening was performed in 72 patients.
Intervention(s): Analysis of chromosomes X, Y, 13, 16, 18, 21 and 22 was carried out with the fluorescence in situ hybridization technique in a blastomere biopsied from day 3 embryos in the study group.
Main Outcome Measure(s): The primary endpoint is implantation rate. Secondary endpoints are embryo morphology and chromosomal status, number of transferred embryos and clinical pregnancy rate.
Result(s): There is no significant difference of the implantation rate between the study group (18.4%) and the control group (26.8%). The number of embryos replaced is significantly lower in the control group, namely 2.1 versus 1.4 in the control group.
Conclusion(s): Preimplantation genetic screening does not increase the implantation rates after IVF-ICSI in women with recurrent failed implantation.
|- Main changes (audit trail)|
|- RECORD||11-jun-2008 - 25-jul-2008|