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van CCT (UK)

van CCT (UK)

Effect of lowering the transition metals and ammonium concentration in human culture media on the quality of the human embryos.

- candidate number4720
- NTR NumberNTR1581
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-dec-2008
- Secondary IDsGIFTNFC2009-1 intern
- Public TitleEffect of lowering the transition metals and ammonium concentration in human culture media on the quality of the human embryos.
- Scientific TitleRemoval of transition metals and ammonium from human IVF culture system.
- ACRONYMTramm-ex
- hypothesisRemoval of transition metals and ammonium from human IVF culture system by an inorganic ion exchanger in the form of a zeolite block packed in gelatine will improve the health and quality of cultured human embryos.
- Healt Condition(s) or Problem(s) studiedIn vitro fertilization (IVF)
- Inclusion criteriaPatients entering the IVF/ICSI program.
- Exclusion criteria1. ICSI cases for preimplantation genetic diagnosis;
2. ICSI cases with testicular spermatozoa.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2009
- planned closingdate1-jan-2010
- Target number of participants100
- InterventionsEmbryo culture will be performed with or without the inorganic ionexchanger Tramm-ex. The randomisation is performed by ‘the research randomizer’ on 100 consecutive patients undergoing IVF/ICSI treatment in each centre. Each centre receives a list for randomisation. Randomisation is performed at the time of check for fertilisation. Embryo scoring and selection for transfer and/or cryopreservation is done according to standard methods. Single embryo transfer from either culture system is done on day 3, 4 or 5.
- Primary outcomeEmbryo quality (quality and cell number in embryo) and clinical pregnancy rate.
- Secondary outcome1. Metabolomic profiling of embryo culture medium;
2. delivery rate;
3. health of baby.
- TimepointsEmbryo quality (during the 5-day embryo culture) and clinical pregnancy rate (12 days and 6 weeks after embryo transfer).
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator GIFT, LIFE
- Funding
(Source(s) of Monetary or Material Support)
Birr Biosciences
- PublicationsN/A
- Brief summaryThe presence of ammonium in human embryo culture medium has a negative effect on embryo physiology and biochemistry. Ammonium concentration will increase due to spontaneous degradation of amino acids as well as by the metabolism of the embryo. Traces of transition metals like copper or iron can have a detrimental effect on embryo development as well. Removal of these embryo-toxic elements during embryo culture could improve the health and quality of the human embryo. Tramm-ex is a zeolite block with cross linked gelatin and is an inorganic ion exchanger. Laboratory test have shown that Tramm-ex removes 50% of the ammonium content as well as a factor 100.000 of the transition metals from culture medium. Zeolite has no negative effect on mouse embryo development. The sperm survival test did not identify the Tramm-ex blocks as embryotoxic. In this prospective randomised study, human embryos will be cultured with and without Tramm-ex. Embryo quality and health as well as clinical pregnancy rates will be evaluated.
- Main changes (audit trail)
- RECORD12-dec-2008 - 3-feb-2009

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