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AzTrials

AzoospermiaNCT06524258

Testicular Elastography for Microscopic Testicular Sperm Extraction

A study testing testicular elastography in people with Azoospermia and Elasticity Imaging Techniques, run by Uşak University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Before commencing our study, we obtained approval from the local ethics committee. The study focused on patients who visited our urology outpatient clinic for infertility between January 2020 and March 2021. Eighty-four patients diagnosed with non-obstructive azoospermia were prospectively enrolled in the study. Read more about this study

Who is it for?
Ages 18 to 65 years, men onlyHealthy volunteers can take part
What is being tested?
testicular elastography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2020to 30 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • non obstructive azoospermia
  • testicular elastography performed
  • micro tese performed

Who cannot join

  • obstructive azoospermia
  • testicular elastography not performed
  • micro tese not performed

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Harran Üniversitesi

    Sanliurfa, Halilye, 63290

Other trials in Turkey (Türkiye)

About this study

Official title: Testicular Elastography for Predicting the Likelihood of Sperm Retrieval in Microscopic Testicular Sperm Extraction

Before commencing our study, we obtained approval from the local ethics committee. The study focused on patients who visited our urology outpatient clinic for infertility between January 2020 and March 2021. Eighty-four patients diagnosed with non-obstructive azoospermia were prospectively enrolled in the study.

Azoospermia was diagnosed after performing semen analysis at least twice, adhering to the criteria outlined by the WHO. All patients underwent karyotype analysis and Y microdeletion analysis. Testicular volumes were measured using Prader orchidometry and confirmed by scrotal ultrasonography.

Read more

For patients scheduled for Micro-TESE, elastography measurements were conducted in the supine position. These measurements were performed by the same radiologist in the Radiology department. A total of six points Shear Wave Elastography (SWE) measurements were recorded from each patient, including upper right, middle right, lower right, upper left, middle left, and lower left.

All patients underwent the micro-TESE procedure by the same surgeon. The procedure was first applied to the testis with a better volume and consistency. Samples of large and bright tubules were extracted using microforceps under a microscope, utilizing a magnification range of 20X-25X. The tissues obtained were subsequently assessed by the same embryologist who was present in the operating room. The embryologist provides biopsy results indicating the presence or absence of spermatozoa. If five or more mature spermatozoa are observed within the testicular tissues, the procedure is terminated. However, if fewer than five spermatozoa are identified in the tissues, the procedure is repeated on the contralateral testicle to ensure a comprehensive examination and thorough exploration. Tissues containing a satisfactory quantity of sperm were processed and preserved in the incubator until the Intracytoplasmic Sperm Injection (ICSI) procedure which was planned following the sperm cryopreservation of the patients whose sperms could be retrieved. In cases where sperm could not be retrieved from patients, testicular tissue was placed in Bouin's solution and sent for histopathological examination.

Read the detailed description

Before commencing our study, we obtained approval from the local ethics committee. The study focused on patients who visited our urology outpatient clinic for infertility between January 2020 and March 2021. Eighty-four patients diagnosed with non-obstructive azoospermia were prospectively enrolled in the study. Patients with obstructive azoospermia, hypogonadotropic hypogonadism, history of previous testicular disease, previous TESE, and history of chemotherapy or radiotherapy were excluded from the study.

Azoospermia was diagnosed after performing semen analysis at least twice, adhering to the criteria outlined by the WHO. All patients underwent karyotype analysis and Y microdeletion analysis. Testicular volumes were measured using Prader orchidometry and confirmed by scrotal ultrasonography.

For patients scheduled for Micro-TESE, elastography measurements were conducted in the supine position. These measurements were performed by the same radiologist in the Radiology department. A total of six points Shear Wave Elastography (SWE) measurements were recorded from each patient, including upper right, middle right, lower right, upper left, middle left, and lower left.

All patients underwent the micro-TESE procedure by the same surgeon. The procedure was first applied to the testis with a better volume and consistency. Samples of large and bright tubules were extracted using microforceps under a microscope, utilizing a magnification range of 20X-25X. The embryologist provides biopsy results indicating the presence or absence of spermatozoa. If five or more mature spermatozoa are observed within the testicular tissues, the procedure is terminated. However, if fewer than five spermatozoa are identified in the tissues, the procedure is repeated on the contralateral testicle to ensure a comprehensive examination and thorough exploration. Tissues containing a satisfactory quantity of sperm were processed and preserved in the incubator until the Intracytoplasmic Sperm Injection (ICSI) procedure which was planned following the sperm cryopreservation of the patients whose sperms could be retrieved. In cases where sperm could not be retrieved from patients, testicular tissue was placed in Bouin's solution and sent for histopathological examination.

Being tested
testicular elastography
Keywords
share wave elastography, microscopic testicular sperm extraction, azoospermia
Medical subject headings
Azoospermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • testicular elastographyDiagnostic test

    testicular elastography for predicting non obstructive azoospermia

Study groups in NCT06524258
Study groupRoleWhat they receive
tese positiveOthermicro tese positive
Receives: Diagnostic Test: testicular elastography
tese negativeOthermicro tese negative
Receives: Diagnostic Test: testicular elastography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. shear wave elastography right upper pole of the testes

    Elastography measurements of the right upper pole of the testes were conducted in all patients in the supine position using ultrasonography before the operation.

    Measured: 1 day before micro-TESE surgery

  2. shear wave elastography right middle pole of the testes

    Elastography measurements of the right middle pole of the testes were conducted in all patients in the supine position using ultrasonography before the operation.

    Measured: 1 day before micro-TESE surgery

  3. shear wave elastography right lower pole of the testes

    Elastography measurements of the right lower pole of the testes were conducted in all patients in the supine position using ultrasonography before the operation.

    Measured: 1 day before micro-TESE surgery

  4. shear wave elastography left upper pole of the testes

    Elastography measurements of the left upper pole of the testes were conducted in all patients in the supine position using ultrasonography before the operation.

    Measured: 1 day before micro-TESE surgery

  5. shear wave elastography left middle pole of the testes

    Elastography measurements of the left middle pole of the testes were conducted in all patients in the supine position using ultrasonography before the operation.

    Measured: 1 day before micro-TESE surgery

  6. shear wave elastography left lower pole of the testes

    Elastography measurements of the left lower pole of the testes were conducted in all patients in the supine position using ultrasonography before the operation.

    Measured: 1 day before micro-TESE surgery

Secondary outcomes (1)
  1. micro-tese surgery sperm retrieval

    All patients underwent the micro-TESE procedure by the same surgeon.Patients were evaluated as positive or negative based on sperm retrieval results.

    Measured: 1 day after shear wave elastography measurement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2024
  2. Study start1 Jan 2020
  3. Primary completion1 Mar 2021
  4. Study completion30 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06524258
Sponsor's protocol ID
HRÜ-TUNÇEKİN-001
Status last verified
Jul 2024
First submitted
16 Jul 2024
Last updated
29 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zegers-Hochschild F, Adamson GD, de Mouzon J, Ishihara O, Mansour R, Nygren K, Sullivan E, Vanderpoel S; International Committee for Monitoring Assisted Reproductive Technology; World Health Organization. International Committee for Monitoring Assisted Reproductive Technology (ICMART) and the World Health Organization (WHO) revised glossary of ART terminology, 2009. Fertil Steril. 2009 Nov;92(5):1520-4. doi: 10.1016/j.fertnstert.2009.09.009. Epub 2009 Oct 14.

    PubMed 19828144
  • Agarwal A, Baskaran S, Parekh N, Cho CL, Henkel R, Vij S, Arafa M, Panner Selvam MK, Shah R. Male infertility. Lancet. 2021 Jan 23;397(10271):319-333. doi: 10.1016/S0140-6736(20)32667-2. Epub 2020 Dec 10.

    PubMed 33308486
  • Sharlip ID, Jarow JP, Belker AM, Lipshultz LI, Sigman M, Thomas AJ, Schlegel PN, Howards SS, Nehra A, Damewood MD, Overstreet JW, Sadovsky R. Best practice policies for male infertility. Fertil Steril. 2002 May;77(5):873-82. doi: 10.1016/s0015-0282(02)03105-9. No abstract available.

    PubMed 12009338
  • Sharma M, Leslie SW. Azoospermia. 2023 Nov 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK578191/

    PubMed 35201719
  • Practice Committee of American Society for Reproductive Medicine in collaboration with Society for Male Reproduction and Urology. The management of infertility due to obstructive azoospermia. Fertil Steril. 2008 Nov;90(5 Suppl):S121-4. doi: 10.1016/j.fertnstert.2008.08.096.

    PubMed 19007607
  • Bernie AM, Ramasamy R, Schlegel PN. Predictive factors of successful microdissection testicular sperm extraction. Basic Clin Androl. 2013 Oct 2;23:5. doi: 10.1186/2051-4190-23-5. eCollection 2013.

    PubMed 25763186
  • Flannigan R, Bach PV, Schlegel PN. Microdissection testicular sperm extraction. Transl Androl Urol. 2017 Aug;6(4):745-752. doi: 10.21037/tau.2017.07.07.

    PubMed 28904907
  • Baleato-Gonzalez S, Osorio-Vazquez I, Flores-Rios E, Santiago-Perez MI, Laguna-Reyes JP, Garcia-Figueiras R. Testicular Evaluation Using Shear Wave Elastography (SWE) in Patients with Varicocele. J Imaging. 2023 Aug 22;9(9):166. doi: 10.3390/jimaging9090166.

    PubMed 37754930
  • Schurich M, Aigner F, Frauscher F, Pallwein L. The role of ultrasound in assessment of male fertility. Eur J Obstet Gynecol Reprod Biol. 2009 May;144 Suppl 1:S192-8. doi: 10.1016/j.ejogrb.2009.02.034. Epub 2009 Mar 20.

    PubMed 19303691
  • Herek D, Cakmak V, Comut E, Herek O. The value of multimodal ultrasonography in the evaluation of late presenting testicular torsion in a rat experimental model. Br J Radiol. 2024 Feb 2;97(1154):377-385. doi: 10.1093/bjr/tqad059.

    PubMed 38302083
  • Lin YY, Mao L, Li J, Zhu ZM, Luo YH, Zhou XH, Qiu SD, Chen F. Exploring the anatomical factors influencing testes elasticity via ultrasound shear wave elastography: Preliminary results. Rev Int Androl. 2023 Oct-Dec;21(4):100367. doi: 10.1016/j.androl.2023.100367. Epub 2023 Jul 7.

    PubMed 37422973
  • Illiano E, Trama F, Ruffo A, Romeo G, Riccardo F, Crocetto F, Iacono F, Costantini E. Testicular shear wave elastography in oligo-astheno-teratozoospermic individuals: a prospective case-control study. Int Urol Nephrol. 2021 Sep;53(9):1773-1783. doi: 10.1007/s11255-021-02909-4. Epub 2021 Jun 10.

    PubMed 34114152
  • Harris SE, Sandlow JI. Sperm acquisition in nonobstructive azoospermia: what are the options? Urol Clin North Am. 2008 May;35(2):235-42, ix. doi: 10.1016/j.ucl.2008.01.008.

    PubMed 18423244
  • Schlegel PN. Testicular sperm extraction: microdissection improves sperm yield with minimal tissue excision. Hum Reprod. 1999 Jan;14(1):131-5. doi: 10.1093/humrep/14.1.131.

    PubMed 10374109
  • Arian I, Dumbraveanu I, Ghenciu V, Machidon D, Ernu I, Ceban E. Histological and immunohistochemical outcomes after microdissection TESE in contrast with hormonal profile, testis volume and genetics in patients with azoospermia. J Med Life. 2023 Jan;16(1):144-152. doi: 10.25122/jml-2022-0336.

    PubMed 36873127

Questions about this trial

What is this clinical trial studying?

A study testing testicular elastography in people with Azoospermia and Elasticity Imaging Techniques, run by Uşak University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

shear wave elastography right upper pole of the testes (time frame: 1 day before micro-TESE surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06524258, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024; AzTrials last refreshed its copy on 30 Oct 2026.

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