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A multi-center double-blind randomized controlled trial of two media for the in vitro culture of human preimplantation embryos.


- candidate number6385
- NTR NumberNTR1979
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-sep-2009
- Secondary IDsN/A 
- Public TitleA multi-center double-blind randomized controlled trial of two media for the in vitro culture of human preimplantation embryos.
- Scientific TitleA multi-center double-blind randomized controlled trial of two media for the in vitro culture of human preimplantation embryos.
- ACRONYMN/A
- hypothesisTo investigate whether the use of G5-medium for the in vitro culture of human preimplantation embryos leads to an improved live birth rate per patient as compared to the use of HTF-medium.
- Healt Condition(s) or Problem(s) studiedInfertility, Subfertility
- Inclusion criteriaSubfertile couples undergoing IVF (in vitro fertilization) or ICSI (intracytoplasmatic sperm injection).
- Exclusion criteria1. Couples undergoing a PGD cycle;
2. Couples for which IVF is used to prevent the transmission of HIV;
3. Couples undergoing a modified natural cycle.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingTriple
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 9-jan-2009
- planned closingdate9-jan-2012
- Target number of participants784
- InterventionsOvarian hyperstimulation, oocyte retrieval and oocyte fertilization will be performed using standard procedures. In the experimental arm, all oocytes and resulting embryos will be cultured in G5-medium and in the control arm, oocytes and resulting embryos will be cultured in HTF-medium.
- Primary outcomePrimary outcome measure will be live birth rate per patient after one year of treatment.
- Secondary outcomeSecondary outcome measures will be embryo quality, clinical pregnancy rate, ongoing pregnancy rate, miscarriage rate, time to pregnancy, birth weight and percentage of children with congenital abnormalities.
- TimepointsThe duration of the study is three years.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Sebastiaan Mastenbroek
- CONTACT for SCIENTIFIC QUERIESDr. Sebastiaan Mastenbroek
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryThis study investigates whether the use of G5-medium for the in vitro culture of human preimplantation embryos leads to an improved live birth rate per patient as compared to the use of HTF-medium.
- Main changes (audit trail)
- RECORD1-sep-2009 - 12-okt-2009


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl