Sperm Capacitation Assay as a Tool to Predict Sperm Poten... | NCT00731159

Studies
Sperm Capacitation Assay as a Tool to Predict Sperm Potential to Fertilize in IVF Treatment

NCT00731159

Sponsor

Assaf-Harofeh Medical Center

Status

Unknown status

Last Update Posted

Aug 8, 2008Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Sperm Capacitation

Interventions

sperm capacitation
biologic
sperm capacitation

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

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Jan 2009Estimated

Completion Date

Jul 2009Estimated

First Submitted Date

Aug 7, 2008

First Submission Date that Met QC Criteria

Aug 7, 2008

First Posted Date

Aug 8, 2008Estimated

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 7, 2008

Last Update Posted Date

Aug 8, 2008Estimated

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

Our aim is to evaluate the potential of a new laboratory method that measure sperm capacitation to predict fertilization of oocytes in patients that undergo IVF treatments

Detailed Description

Capacitation is a physiologic process in which the sperm acquire the potential to fertilize oocytes. Capacitation can be measured, but the available technics are expensive, inaccurate and complex. A new method to evaluate sperm capacitation was developed in Bar Ilan University, Israel. We intend to measure the capacitation of semen that is used for fertilizing human oocytes in patients treated at the IVF unit at Assaf Harofeh Medical Center.By this, to evaluate the potential of the new method to predict human oocyte fertilization.If the method will be found valuable, it will enable to develop new drugs/methods that may improve sperm capacitation and by this to improve oocyte fertilization leading to more embryos, pregnancies and deliveries.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A		Sperm capacitation: Sperm capacitation is measured in a sample of the same ejaculated sperm unit given for fertilizing human oocytes in an IVF treatment cycle	Biological: sperm capacitation Other: biologic Other: sperm capacitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sperm capacitation	Biological	sperm capacitation measured at Bar Ilan University	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fertilization rate of human oocytes in thr "routine" IVF Laboratory work		One year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients requiring IVF within the "routine" work of an IVF Unit
normo-responding woman
non ICSI cycles

Exclusion Criteria:

Patients undergoing ICSI only cycle
Low responders-less than 8 oocytes
Male patients with low semen volume

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Patients requiring IVF within the "routine" work of an IVF Unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
arieh raziel, prof	Contact	97289779005		araziel@asaf.health.gov.il
raphael ron-el, prof	Contact	97289779005		rronel@asaf.health.gov.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assaf Harofeh MC	Recruiting	Beer Yaacov	Zerifin	70300	Israel

Intervention Browse Module

MeSH Terms

ID	Term
D013075	Sperm Capacitation
D001688	Biological Products

Ancestor Terms

ID	Term
D005306	Fertilization
D012098	Reproduction
D055703	Reproductive Physiological Phenomena
D012101	Reproductive and Urinary Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided