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Prospective randomized sibling-oocyte study using recombinant human hyaluronidase Cumulase® versus Sigma hyaluronidase in ICSI patients.


- candidate number2589
- NTR NumberNTR979
- ISRCTNISRCTN89831716
- Date ISRCTN created27-jun-2007
- date ISRCTN requested11-jun-2007
- Date Registered NTR24-mei-2007
- Secondary IDsHZ2-05-07 protocol number
- Public TitleProspective randomized sibling-oocyte study using recombinant human hyaluronidase Cumulase® versus Sigma hyaluronidase in ICSI patients.
- Scientific TitleProspective randomized sibling-oocyte study using recombinant human hyaluronidase Cumulase® versus Sigma hyaluronidase in ICSI patients.
- ACRONYMN/A
- hypothesisNon-inferiority trial in order to evaluate the effectiveness of the new compound (recombinant human hyaluronidase or Cumulase®), effectiveness being defined by intactness after ICSI and fertilization rate.
- Healt Condition(s) or Problem(s) studiedCumulus cell , Hyaluronidase, Intracytoplasmic sperm injection (ICSI), Prospective study
- Inclusion criteriaWomen undergoing ICSI treatment with fresh ejaculate sperm cells, no older than 38 years of age and presenting between 8 and 16 cumulus oocyte complexes(COC's) at ovum pick up.
- Exclusion criteria1. Surgically extracted sperm preparations;
2. Embryo biopsy cycles;
3. Women older than 38 years;
4. Women with less than 8 or more than 16 COC's.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2006
- planned closingdate28-feb-2007
- Target number of participants135
- InterventionsOocyte denudation (i.e. removal of the surrounding cumulus and corona cells, in preparation to ICSI).
- Primary outcome1. Oocyte intactness after ICSI;
2. Fertilization rate.
- Secondary outcome1. Embryo development;
2. Positive hCG after embryo transfer.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf. dr. Josiane Elst, Van der
- CONTACT for SCIENTIFIC QUERIESphD Anick Vos, De
- Sponsor/Initiator Universitair Ziekenhuis Brussel (UZB), Centrum Medische Genetica en Centrum Reproductieve Geneeskunde
- Funding
(Source(s) of Monetary or Material Support)
Universitair Ziekenhuis Brussel, Centrum Medische Genetica en Centrum Reproductieve Geneeskunde, Halozyme Therapeutics Inc., San Diego, USA
- PublicationsThe results of the study will be presented at the yearly congress of ESHRE Lyon 2007 and they are intended to be published soon after (intention to submit to Human Reproduction).
- Brief summaryIncubation time and effectiveness of denudation were not different for the two enzymes. Similar ICSI oocyte survival rates and fertilization rates were obtained. Cumulase® treatment of the oocytes is compatible with positive hCG after embryo transfer. Cumulase® has the strict advantage of being a non-animal product for use in the human.
- Main changes (audit trail)
- RECORD24-mei-2007 - 16-nov-2009


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