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

• Sponsor: Ibn Sina Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03778736
• Collaborator: Banoon IVF Center (Other), Quena IVF Center (Other)
• Enrollment: 586
• Locations: 3
• Arms: 2
• Actual Duration (Months): 18.2
• Patients Per Site: 195.3
• Patients Per Site Per Month: 10.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Other: Cumulase denudation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 586 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Can Cumulase Reduce the Shear Stress During Denudation for ICSI Cycles of ≤ 8 Cumulus-oocytes Complexes
• Actual Study Start Date: Jan 27, 2018
• Actual Primary Completion Date: Aug 1, 2019
• Actual Study Completion Date: Aug 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cumulase denudation	Other: Cumulase denudation; Testing the effect of cumulase for women with poor oocyte yield due to poor ovarian reserve
No Intervention: Hyaluronidase denudation

Outcome Measures

Primary Outcome Measures

1. Ongoing pregnancy rate [16 weeks]

   Continued pregnancy after 12 weeks of gestation

Secondary Outcome Measures

1. Biochemical pregnancy [Two weeks]

   Positive b-hCG at two weeks or more after embryo transfer

2. Clinical pregnancy rate [7 weeks]

   Detection of gestational sac with a heartbeat on ultrasound at 7 weeks of gestation

3. Embryo developmental rate [6 days of culture]

   fertilized oocytes per injected oocytes and developed embryos per fertilized oocytes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ICSI indicated partcipants

Exclusion Criteria:

• severe medical disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banon Assiut	Assiut		Egypt
2	Qena Fertility Center	Qena		Egypt	123456
3	IbnSina IVF Center	Sohag		Egypt

Sponsors and Collaborators

• Ibn Sina Hospital
• Banoon IVF Center
• Quena IVF Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Muhammad Fawzy, IVF Lab Director, Ibn Sina Hospital
• ClinicalTrials.gov Identifier: NCT03778736
• Other Study ID Numbers: IbnSina-Cumulase
• First Posted: Dec 19, 2018
• Last Update Posted: Aug 7, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of Aug 7, 2019