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

NCT ID: NCT03778736

Last Updated: 2019-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

586 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-27

Study Completion Date

2019-08-05

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cumulase denudation

Group Type EXPERIMENTAL

Cumulase denudation

Intervention Type OTHER

Testing the effect of cumulase for women with poor oocyte yield due to poor ovarian reserve

Hyaluronidase denudation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cumulase denudation

Testing the effect of cumulase for women with poor oocyte yield due to poor ovarian reserve

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ICSI indicated partcipants

Exclusion Criteria

* severe medical disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Banoon IVF Center

OTHER

Sponsor Role collaborator

Quena IVF Center

UNKNOWN

Sponsor Role collaborator

Ibn Sina Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Muhammad Fawzy

IVF Lab Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Qena Fertility Center

Qina, Qena Governorate, Egypt

Site Status

Banon Assiut

Asyut, , Egypt

Site Status

IbnSina IVF Center

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IbnSina-Cumulase

Identifier Type: -

Identifier Source: org_study_id

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