Spermatogonial Stem Cells in Azoospermic Patients: a Comp... | NCT01178463

Studies
Spermatogonial Stem Cells in Azoospermic Patients: a Comparison Between Obstructive and Non-obstructive Azoospermia

NCT01178463

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Aug 10, 2010Estimated

Enrollment

25Estimated

Phase

Not provided

Conditions

Male Infertility

Interventions

Biospecimen staining
Biospecimen staining

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

Aug 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

May 2010Actual

Completion Date

Oct 2010Estimated

First Submitted Date

Aug 9, 2010

First Submission Date that Met QC Criteria

Aug 9, 2010

First Posted Date

Aug 10, 2010Estimated

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 9, 2010

Last Update Posted Date

Aug 10, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The researchers hypothesized that nonobstructive azoospermia might be associated with a reduction OF SSCs in seminiferous tubules as compared with obstructive azoospermia. Testicular sperm specimens that had been previously extracted from azoospermic patients will be paraffin embedded and stained with anti GPR-125. After antigen retrieval, the sections will be incubated with rabbit anti GPR125 followed by Cy3-conjugated anti rabbit secondary antibodies. Those found to be SSCs will be counted using light microscopy, and compared between patients with obstructive (n=11) and non-obstructive azoospermia (n=9).

Detailed Description

Not provided

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

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I. Obstructive Azoospermia			Other: Biospecimen staining
II. Non-Obstructive Azoospermia Patients			Other: Biospecimen staining

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biospecimen staining	Other	The sections will be incubated with rabbit anti GPR125 followed by Cy3-conjugated anti rabbit secondary antibodies.	I. Obstructive Azoospermia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SSCs were identified in both obstructive and nonobstructive azoospermia patients.		One year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Azoospermic patients

Exclusion Criteria:

Patients with sperm cells

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Infertile male patients treated at the Hillel Yaffe Medical Center IVF Unit

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center - IVF Unit		Hadera		38100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D007248	Infertility, Male

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007246	Infertility

Browse Leaves

Not provided

Browse Branches

Not provided