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Trial record 5 of 432 for:    Recruiting, Not yet recruiting, Available Studies | "Infertility"

Treatment of Severe Male Infertility - Predictive Factors (Imaging) (TESE-MRI)

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ClinicalTrials.gov Identifier: NCT02931721
Recruitment Status : Recruiting
First Posted : October 13, 2016
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Rauni Klami, Turku University Hospital

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).

Condition or disease Intervention/treatment
Male Infertility Diagnostic Test: MRI

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).


Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Treatment of Severe Male Infertility - Predictive Factors (Imaging)
Study Start Date : August 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2019


Group/Cohort Intervention/treatment
MRI Positive
Men with sperm found in MD-TESE
Diagnostic Test: MRI
Pelvis MRI

MRI Negative
Men with no sperm found in MD-TESE
Diagnostic Test: MRI
Pelvis MRI




Primary Outcome Measures :
  1. Functional difference in testicular MRI depending on MD-TESE outcome (=sperm recovery) [ Time Frame: Through study completion, estimated 6 months ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Azoospermic men scheduled for MD-TESE
Criteria

Inclusion Criteria:

  • non obstructive azospermia

Exclusion Criteria:

  • malignancy
  • contraindication for fertility treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931721


Contacts
Contact: Rauni Klami, MD +358407286874 rauni.klami@gmail.com

Locations
Finland
Turku University Hospital, Dept of Obst and Gyn Recruiting
Turku, Finland, 20520
Contact: Rauni Klami, MD    +358407286874    rauni.klami@tyks.fi   
Sub-Investigator: Rauni Klami, MD         
Dept of Obst and Gyn Recruiting
Turku, Finland
Principal Investigator: Antti Perheentupa, MD, PhD         
Sponsors and Collaborators
Turku University Hospital
Investigators
Study Director: Antti Perheentupa, MD,PhD Turku University Hospital

Responsible Party: Rauni Klami, MD, Turku University Hospital
ClinicalTrials.gov Identifier: NCT02931721     History of Changes
Other Study ID Numbers: TESE-MRI
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Rauni Klami, Turku University Hospital:
Azospermia
Micro Dissection Testicular Sperm Extraction
Male infertility
Testis
MRI

Additional relevant MeSH terms:
Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female