Treatment of Severe Male Infertility - Predictive Factors... | NCT02931721

Studies
Treatment of Severe Male Infertility - Predictive Factors (Imaging)

NCT02931721

Sponsor

Turku University Hospital

Status

Completed

Last Update Posted

Nov 1, 2023Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Male Infertility

Interventions

Countries

Finland

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

Oct 2023

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

Nov 1, 2016Actual

Primary Completion Date

Jul 2023Actual

Completion Date

Jul 2023Actual

First Submitted Date

Oct 5, 2016

First Submission Date that Met QC Criteria

Oct 10, 2016

First Posted Date

Oct 13, 2016Estimated

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

Oct 27, 2023

Last Update Posted Date

Nov 1, 2023Actual

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

Testes of men with non-obstructive azoospermia (NOA) are imaged using MRI to find potential differences depending on the outcome, ie. sperm recovery in consequent microdissection testicular sperm extraction (MD-TESE).

Detailed Description

Sperm recovery rate in non-obstructive azoospermia (NOA) men is 43% in Turku University Hospital, depending on the diagnosis leading to NOA. To date, there are no known parameters known to differentiate between successful and unsuccessful sperm recovery.

MRI is performed on men prior to the operation, and the objective is to compare the functional parameters assessed by magnetic resonance imaging between the group of men with positive and the men with negative sperm recovery in testicular microdissection sperm extraction (MD-TESE).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
MRI Positive	Men with sperm found in MD-TESE	Diagnostic Test: MRI
MRI Negative	Men with no sperm found in MD-TESE	Diagnostic Test: MRI
Control group	No intervention, fertile	Diagnostic Test: MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI	Diagnostic Test	Pelvis MRI	Control group MRI Negative MRI Positive

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional difference in testicular MRI depending on MD-TESE outcome (=sperm recovery)	ADC differences by diagnosis and outcome	Baseline/ pre-invention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

non obstructive azospermia

Exclusion Criteria:

malignancy
contraindication for fertility treatment

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Azoospermic men scheduled for MD-TESE

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Antti Perheentupa, MD,PhD	Turku University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Turku University Hospital, Dept of Obst and Gyn		Turku		20520	Finland
Dept of Obst and Gyn

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
D007248	Infertility, Male
D053713	Azoospermia

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided