| - candidate number | 2589 |
| - NTR Number | NTR979 |
| - ISRCTN | ISRCTN89831716 |
| - Date ISRCTN created | 27-jun-2007 |
| - date ISRCTN requested | 11-jun-2007 |
| - Date Registered NTR | 24-mei-2007 |
| - Secondary IDs | HZ2-05-07 protocol number |
| - Public Title | Prospective randomized sibling-oocyte study using recombinant human hyaluronidase Cumulase® versus Sigma hyaluronidase in ICSI patients. |
| - Scientific Title | Prospective randomized sibling-oocyte study using recombinant human hyaluronidase Cumulase® versus Sigma hyaluronidase in ICSI patients. |
| - ACRONYM | N/A |
| - hypothesis | Non-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) studied | Cumulus cell , Hyaluronidase, Intracytoplasmic sperm injection (ICSI), Prospective study |
| - Inclusion criteria | Women 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 criteria | 1. 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 received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-mei-2006 |
| - planned closingdate | 28-feb-2007 |
| - Target number of participants | 135 |
| - Interventions | Oocyte denudation (i.e. removal of the surrounding cumulus and corona cells, in preparation to ICSI). |
| - Primary outcome | 1. Oocyte intactness after ICSI; 2. Fertilization rate. |
| - Secondary outcome | 1. Embryo development; 2. Positive hCG after embryo transfer. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | Prof. dr. Josiane Elst, Van der |
| - CONTACT for SCIENTIFIC QUERIES | phD 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 |
| - Publications | The 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 summary | Incubation 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) | |
| - RECORD | 24-mei-2007 - 16-nov-2009 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl