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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29487
Enrollment
135
Registered
2007-05-24
Start date
2006-05-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cumulus cell removal/hyaluronidase/Cumulase®/ICSI/prospective study

Interventions

Oocyte denudation (i.e. removal of the surrounding cumulus and corona cells, in preparation to ICSI).

Sponsors

Universitair Ziekenhuis Brussel secundaire sponsor: Halozyme Therapeutics Inc., San Diego, USA (free product - Cumulase® - supply for the duration of the study)
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
1. Oocyte intactness after ICSI; 2. Fertilization rate.—

Secondary

MeasureTime frame
1. Embryo development; 2. Positive hCG after embryo transfer.—

Contacts

Public ContactJosiane Elst, Van der

Laboratory Director, Centre for Reproductive Medicine, UZ Brussel, Laarbeeklaan 101

Josiane.Vanderelst@uzbrussel.be+32-2-477.66.90

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)