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.
ID
Bron
Verkorte titel
Aandoening
Subfertility/infertility in women with advanced maternal age.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Ongoing pregnancy rate.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Publiek
P.O. Box 22660
Sebastiaan Mastenbroek
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663090
S.Mastenbroek@amc.uva.nl
Wetenschappelijk
P.O. Box 22660
Sebastiaan Mastenbroek
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663090
S.Mastenbroek@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Women between 35 and 41 years of age, undergoing IVF (in vitro fertilization) or ICSI (intracytoplasmatic sperm injection).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
N/A
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL56 |
NTR-old | NTR84 |
Ander register | : ZON-MW 945-03-013 |
ISRCTN | ISRCTN76355836 |