NCT05958576

Brief Summary

Males with non-obstructive azoospermia (NOA) have an opportunity to obtain sperm by treatment with microdissection testicular sperm extraction (mTESE), gold-standard surgical technique for them. The overall sperm retrieval rate (SRR) of mTESE in NOA patients is about 50%, but the predictive factors of SRR remain were understudied, especially the effect of age. The purpose of this study was to explore the factors influencing the SRR of mTESE in NOA patients with different etiologies. Methods: This observational study recruit NOA patients treated with their first mTESE. The stratified research was used to investigate SRR by dividing patients into seven groups based on etiology. The primary outcome was SRR. Multivariable logistic regression was used to analyze the factors influencing SRR.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,104

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
Last Updated

July 24, 2023

Status Verified

December 1, 2022

Enrollment Period

10.8 years

First QC Date

July 15, 2023

Last Update Submit

July 21, 2023

Conditions

Keywords

non-obstructive azoospermiamicrodissection testicular sperm extractionsperm retrieval rateage

Outcome Measures

Primary Outcomes (1)

  • sperm retrieval rate

    If sperm was observed during the surgery, this case was defined as positive. If sperm wasn't observed, the case was defined as negative.

    immediately after surgery

Eligibility Criteria

Age21 Years - 57 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Non-obstructive azoospermia patients

You may qualify if:

  • Non-obstructive azoospermia patients were treated with microdissection testicular sperm extraction.

You may not qualify if:

  • Obstructive azoospermia patients.
  • Fertile males.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (10)

  • Mittal PK, Little B, Harri PA, Miller FH, Alexander LF, Kalb B, Camacho JC, Master V, Hartman M, Moreno CC. Role of Imaging in the Evaluation of Male Infertility. Radiographics. 2017 May-Jun;37(3):837-854. doi: 10.1148/rg.2017160125. Epub 2017 Apr 14.

  • Tuttelmann F, Werny F, Cooper TG, Kliesch S, Simoni M, Nieschlag E. Clinical experience with azoospermia: aetiology and chances for spermatozoa detection upon biopsy. Int J Androl. 2011 Aug;34(4):291-8. doi: 10.1111/j.1365-2605.2010.01087.x. Epub 2010 Jun 28.

  • Hopps CV, Mielnik A, Goldstein M, Palermo GD, Rosenwaks Z, Schlegel PN. Detection of sperm in men with Y chromosome microdeletions of the AZFa, AZFb and AZFc regions. Hum Reprod. 2003 Aug;18(8):1660-5. doi: 10.1093/humrep/deg348.

  • Forti G, Corona G, Vignozzi L, Krausz C, Maggi M. Klinefelter's syndrome: a clinical and therapeutical update. Sex Dev. 2010 Sep;4(4-5):249-58. doi: 10.1159/000316604. Epub 2010 Jul 21.

  • Krausz C. Male infertility: pathogenesis and clinical diagnosis. Best Pract Res Clin Endocrinol Metab. 2011 Apr;25(2):271-85. doi: 10.1016/j.beem.2010.08.006.

  • Pena VN, Kohn TP, Herati AS. Genetic mutations contributing to non-obstructive azoospermia. Best Pract Res Clin Endocrinol Metab. 2020 Dec;34(6):101479. doi: 10.1016/j.beem.2020.101479. Epub 2020 Dec 15.

  • Ternavasio-de la Vega HG, Boronat M, Ojeda A, Garcia-Delgado Y, Angel-Moreno A, Carranza-Rodriguez C, Bellini R, Frances A, Novoa FJ, Perez-Arellano JL. Mumps orchitis in the post-vaccine era (1967-2009): a single-center series of 67 patients and review of clinical outcome and trends. Medicine (Baltimore). 2010 Mar;89(2):96-116. doi: 10.1097/MD.0b013e3181d63191.

  • Mieusset R, Bujan L, Massat G, Mansat A, Pontonnier F. Clinical and biological characteristics of infertile men with a history of cryptorchidism. Hum Reprod. 1995 Mar;10(3):613-9. doi: 10.1093/oxfordjournals.humrep.a135998.

  • Zhang HL, Zhao LM, Mao JM, Liu DF, Tang WH, Lin HC, Zhang L, Lian Y, Hong K, Jiang H. Sperm retrieval rates and clinical outcomes for patients with different causes of azoospermia who undergo microdissection testicular sperm extraction-intracytoplasmic sperm injection. Asian J Androl. 2021 Jan-Feb;23(1):59-63. doi: 10.4103/aja.aja_12_20.

  • Bonarriba CR, Burgues JP, Vidana V, Ruiz X, Piza P. Predictive factors of successful sperm retrieval in azoospermia. Actas Urol Esp. 2013 May;37(5):266-72. doi: 10.1016/j.acuro.2012.06.002. Epub 2012 Oct 9. English, Spanish.

Study Officials

  • Li Zhang, Ph.D

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2023

First Posted

July 24, 2023

Study Start

March 1, 2012

Primary Completion

December 31, 2022

Study Completion

March 31, 2023

Last Updated

July 24, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

The IPD of this study is openly available to other researchers. You could get them from Li Zhang and please contact her (lizhang0814@163.com).

Locations