search
Back to results

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

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cumulase denudation
Sponsored by
Ibn Sina Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infertility

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • ICSI indicated partcipants

Exclusion Criteria:

  • severe medical disease

Sites / Locations

  • Banon Assiut
  • Qena Fertility Center
  • IbnSina IVF Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cumulase denudation

Hyaluronidase denudation

Arm Description

Outcomes

Primary Outcome Measures

Ongoing pregnancy rate
Continued pregnancy after 12 weeks of gestation

Secondary Outcome Measures

Biochemical pregnancy
Positive b-hCG at two weeks or more after embryo transfer
Clinical pregnancy rate
Detection of gestational sac with a heartbeat on ultrasound at 7 weeks of gestation
Embryo developmental rate
fertilized oocytes per injected oocytes and developed embryos per fertilized oocytes

Full Information

First Posted
December 15, 2018
Last Updated
August 5, 2019
Sponsor
Ibn Sina Hospital
Collaborators
Banoon IVF Center, Quena IVF Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03778736
Brief Title
Using Cumulase for Denudation of Cycles With ≤ 8 Cumulus-oocytes Complexes
Official Title
Can Cumulase Reduce the Shear Stress During Denudation for ICSI Cycles of ≤ 8 Cumulus-oocytes Complexes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 27, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ibn Sina Hospital
Collaborators
Banoon IVF Center, Quena IVF Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
586 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cumulase denudation
Arm Type
Experimental
Arm Title
Hyaluronidase denudation
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Cumulase denudation
Intervention Description
Testing the effect of cumulase for women with poor oocyte yield due to poor ovarian reserve
Primary Outcome Measure Information:
Title
Ongoing pregnancy rate
Description
Continued pregnancy after 12 weeks of gestation
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Biochemical pregnancy
Description
Positive b-hCG at two weeks or more after embryo transfer
Time Frame
Two weeks
Title
Clinical pregnancy rate
Description
Detection of gestational sac with a heartbeat on ultrasound at 7 weeks of gestation
Time Frame
7 weeks
Title
Embryo developmental rate
Description
fertilized oocytes per injected oocytes and developed embryos per fertilized oocytes
Time Frame
6 days of culture

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ICSI indicated partcipants Exclusion Criteria: severe medical disease
Facility Information:
Facility Name
Banon Assiut
City
Assiut
Country
Egypt
Facility Name
Qena Fertility Center
City
Qena
ZIP/Postal Code
123456
Country
Egypt
Facility Name
IbnSina IVF Center
City
Sohag
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs