- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03778736
Using Cumulase for Denudation of Cycles With ≤ 8 Cumulus-oocytes Complexes
August 5, 2019 updated by: Muhammad Fawzy, Ibn Sina Hospital
Can Cumulase Reduce the Shear Stress During Denudation for ICSI Cycles of ≤ 8 Cumulus-oocytes Complexes
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
586
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Assiut, Egypt
- Banon Assiut
-
Qena, Egypt, 123456
- Qena Fertility Center
-
Sohag, Egypt
- IbnSina IVF Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- ICSI indicated partcipants
Exclusion Criteria:
- severe medical disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cumulase denudation
|
Testing the effect of cumulase for women with poor oocyte yield due to poor ovarian reserve
|
No Intervention: Hyaluronidase denudation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ongoing pregnancy rate
Time Frame: 16 weeks
|
Continued pregnancy after 12 weeks of gestation
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemical pregnancy
Time Frame: Two weeks
|
Positive b-hCG at two weeks or more after embryo transfer
|
Two weeks
|
Clinical pregnancy rate
Time Frame: 7 weeks
|
Detection of gestational sac with a heartbeat on ultrasound at 7 weeks of gestation
|
7 weeks
|
Embryo developmental rate
Time Frame: 6 days of culture
|
fertilized oocytes per injected oocytes and developed embryos per fertilized oocytes
|
6 days of culture
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 27, 2018
Primary Completion (Actual)
August 1, 2019
Study Completion (Actual)
August 5, 2019
Study Registration Dates
First Submitted
December 15, 2018
First Submitted That Met QC Criteria
December 15, 2018
First Posted (Actual)
December 19, 2018
Study Record Updates
Last Update Posted (Actual)
August 7, 2019
Last Update Submitted That Met QC Criteria
August 5, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IbnSina-Cumulase
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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