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

Not Applicable

Completed

• Conditions: Infertility

• Registration Number: NCT03778736
• Lead Sponsor: Ibn Sina Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-27
• Study First Submitted: 2018-12-15
• Study First Submitted QC: 2018-12-15
• Study First Posted: 2018-12-19
• Status Verified: 2019-08
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-05
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 586

Inclusion Criteria

• ICSI indicated partcipants

Exclusion Criteria

• severe medical disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	16 weeks	Continued pregnancy after 12 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
Embryo developmental rate	6 days of culture	fertilized oocytes per injected oocytes and developed embryos per fertilized oocytes
Biochemical pregnancy	Two weeks	Positive b-hCG at two weeks or more after embryo transfer
Clinical pregnancy rate	7 weeks	Detection of gestational sac with a heartbeat on ultrasound at 7 weeks of gestation

Trial Locations

Locations (3)

Banon Assiut; 🇪🇬 Assiut, Egypt

Qena Fertility Center; 🇪🇬 Qena, Egypt

IbnSina IVF Center; 🇪🇬 Sohag, Egypt