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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR979 |
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Date of registration:
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24/05/2007 |
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Primary sponsor: |
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Public title:
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Prospective randomized sibling-oocyte study using recombinant human hyaluronidase Cumulase® versus Sigma hyaluronidase in ICSI patients.
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Scientific title:
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Prospective randomized sibling-oocyte study using recombinant human hyaluronidase Cumulase® versus Sigma hyaluronidase in ICSI patients. - N/A |
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Date of first enrolment:
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1/5/2006 |
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Target sample size:
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135 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=979 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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Anick
Vos, De |
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Address:
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Clinical Embryologist, Centre for Reproductive Medicine, UZ Brussel, Laarbeeklaan 101
B-1090
Brussels
Belgium |
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Telephone:
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+32-2-477.66.97 |
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Email:
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anick.devos@uzbrussel.be |
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Affiliation:
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Name:
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Josiane
Elst, Van der |
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Address:
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Laboratory Director, Centre for Reproductive Medicine, UZ Brussel, Laarbeeklaan 101
B-1090
Brussels
Belgium |
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Telephone:
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+32-2-477.66.90 |
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Email:
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Josiane.Vanderelst@uzbrussel.be |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Cumulus cell , Hyaluronidase, Intracytoplasmic sperm injection (ICSI), Prospective study
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Intervention(s)
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Oocyte denudation (i.e. removal of the surrounding cumulus and corona cells, in preparation to ICSI).
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Primary Outcome(s)
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1. Oocyte intactness after ICSI;
2. Fertilization rate.
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Secondary Outcome(s)
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1. Embryo development;
2. Positive hCG after embryo transfer.
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Secondary ID(s)
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HZ2-05-07
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ISRCTN89831716
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Source(s) of Monetary Support
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Universitair Ziekenhuis Brussel, Centrum Medische Genetica en Centrum Reproductieve Geneeskunde, Halozyme Therapeutics Inc., San Diego, USA
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