Using Cumulase for Denudation of Cycles With ≤ 8 Cumulus-... | NCT03778736

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

NCT03778736

Sponsor

Ibn Sina Hospital

Status

Completed

Last Update Posted

Aug 7, 2019Actual

Enrollment

586Actual

Phase

Not Applicable

Conditions

Infertility

Interventions

Cumulase denudation

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 27, 2018Actual

Primary Completion Date

Aug 1, 2019Actual

Completion Date

Aug 5, 2019Actual

First Submitted Date

Dec 15, 2018

First Submission Date that Met QC Criteria

Dec 15, 2018

First Posted Date

Dec 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2019

Last Update Posted Date

Aug 7, 2019Actual

Name	Class
Banoon IVF Center	OTHER
Quena IVF Center	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

586Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cumulase denudation	Experimental		Other: Cumulase denudation
Hyaluronidase denudation	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cumulase denudation	Other	Testing the effect of cumulase for women with poor oocyte yield due to poor ovarian reserve	Cumulase denudation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ongoing pregnancy rate	Continued pregnancy after 12 weeks of gestation	16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Biochemical pregnancy	Positive b-hCG at two weeks or more after embryo transfer	Two weeks
Clinical pregnancy rate	Detection of gestational sac with a heartbeat on ultrasound at 7 weeks of gestation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ICSI indicated partcipants

Exclusion Criteria:

severe medical disease

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Qena Fertility Center		Qina	Qena Governorate	123456	Egypt
Banon Assiut

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided