NCT03778736

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
586

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2019

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

1.5 years

First QC Date

December 15, 2018

Last Update Submit

August 5, 2019

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate

    Continued pregnancy after 12 weeks of gestation

    16 weeks

Secondary Outcomes (3)

  • Biochemical pregnancy

    Two weeks

  • Clinical pregnancy rate

    7 weeks

  • Embryo developmental rate

    6 days of culture

Study Arms (2)

Cumulase denudation

EXPERIMENTAL
Other: Cumulase denudation

Hyaluronidase denudation

NO INTERVENTION

Interventions

Cumulase denudationOTHER

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

Cumulase denudation

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ICSI indicated partcipants

You may not qualify if:

  • severe medical disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Qena Fertility Center

Qina, Qena Governorate, 123456, Egypt

Location

Banon Assiut

Asyut, Egypt

Location

IbnSina IVF Center

Sohag, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
IVF Lab Director

Study Record Dates

First Submitted

December 15, 2018

First Posted

December 19, 2018

Study Start

January 27, 2018

Primary Completion

August 1, 2019

Study Completion

August 5, 2019

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(3)