Fertilizations With Immotile Sperm: Pentoxyphylline Activ... | NCT02051075

Studies
Fertilizations With Immotile Sperm: Pentoxyphylline Activation Alone, or With Chemical Oocyte Activation

NCT02051075

Sponsor

Rambam Health Care Campus

Status

Withdrawn

Last Update Posted

May 6, 2015Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Infertility

Interventions

PXN sperm treatment
Sperm activation with PXN and oocyte activation

Countries

Israel

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

ID	Type	Description	Link
0443-13-RMB	Other Identifier	Rambam Medical Center

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

failure to recruit

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Jan 29, 2014

First Submission Date that Met QC Criteria

Jan 30, 2014

First Posted Date

Jan 31, 2014Estimated

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

May 5, 2015

Last Update Posted Date

May 6, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Immotile sperm is a rather frequent problem encountered in IVF patients. Treatment is usually based on inducing motility with pentoxyphylline (PXN) followed by ICSI. However, fertilization rate with this method is still lower compared with ICSI using motile sperm. One of the reasons for that is the immotile sperm inability to activate the oocyte Our research hypothesis is that better fertilization rate can be accomplished in these cases by combining PXN sperm activation with Ca ionophore oocyte activation.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PXN only	Active Comparator	Sperm activation with PXN before ICSI	Biological: PXN sperm treatment
PXN activation and oocyte activation	Experimental	Sperm activation with PXN and oocyte activation	Biological: Sperm activation with PXN and oocyte activation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PXN sperm treatment	Biological	immotile sperm activation with PXN	PXN only

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical pregnancy	Demonstration of fetal heart activity 1 month post oocyte retrieval.	One month post oocyte retrieval

Secondary Outcomes

Measure	Description	Time Frame
Fertilization rate	Normal, 2 pronuclei, zygote one day post ICSI	One day post oocyte retrieval

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women up to 35 years of age
immotile sperm
At least 6 mature eggs

Exclusion Criteria:

globozoospermia
"Freeze all" cycles because of OHSS risk.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 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
Rambam medical Center		Haifa	Israel	31096	Israel

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility
D053627	Asthenozoospermia

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007248	Infertility, Male
D005832	Genital Diseases, Male

Browse Leaves

Not provided

Browse Branches

Not provided