Using Cumulase for Denudation of Cycles With ≤ 8 Cumulus-oocytes Complexes

Ibn Sina Hospital

Status: Completed

Conditions: Infertility

Treatments: Other: Cumulase denudation

Study type: Interventional

Funder types: Other

Identifiers

NCT03778736

IbnSina-Cumulase

Details and patient eligibility

About

The cumulus-corona-oocyte complex (COCs) surrounds each oocyte and must be removed prior to intracytoplasmic sperm injection (ICSI). This is traditionally achieved with a bovine-derived hyaluronidase followed by mechanical denudation through pipetting. A human recombinant hyaluronidase (Cumulase) has been developed to circumvent the problems and concerns associated with the animal origin and lack of purity of the bovine-derived form of the enzyme. whether cumulase offers a higher chance for success after ICSI for women with 8 COCs or lower remains an open question.

Enrollment: 586 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ICSI indicated partcipants

Exclusion criteria

• severe medical disease

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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586 participants in 2 patient groups

Cumulase denudation

Experimental group

Treatment:

Other: Cumulase denudation

Hyaluronidase denudation

No Intervention group