Effect of Age on Sperm Recovery of Microdissection Testicular Sperm Extraction in Nonobstructive Azoospermia Patients

NCT ID: NCT05958576

Last Updated: 2023-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-01

Study Completion Date

2023-03-31

Brief Summary

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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.

Detailed Description

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As the most severe form of infertility, azoospermia is observed in approximately 10% to 15% of infertile males and can be classified as obstructive azoospermia (OA) and non-obstructive azoospermia (NOA), the latter of which cause spermatogenic dysfunction. Approximately 60% of NOA males are diagnosed with congenital, acquired, or idiopathic NOA (iNOA). The most common congenital causes of NOA are Klinefelter syndrome (KS) and Y chromosome azoospermia factor (AZF) deletions, whereas the acquired causes of NOA are mumps orchitis, cryptorchidism, cryptozoospermia, and iatrogenic causes (chemotherapy, radiotherapy, hypogonadotropic hypogonadism). For iNOA, the most common form of NOA, there is no clear cause in approximately 50-80% of cases.

As a prevalent chromosomal abnormality, KS with two or more X chromosomes is the most common form of congenital NOA that affects approximately 3-4% of infertile males and more than 10% of azoospermic males. The incidence of Y-chromosome AZF microdeletions in fertile males is 0.025%, but it increases to 2%-10% in infertile males. Mumps orchitis is the most common and serious complication of mumps virus infection in adolescents and young adults, with an incidence of 40% in males with postpubertal mumps, and approximately 30% of males suffer from infertility or subfertility. As an extremely severe form of oligozoospermia, cryptozoospermia is characterized by the absence of sperm in semen by microscopic examination but the presence of sperm in centrifuge sediment, with an incidence of approximately 8.73% in infertile males. Cryptorchidism represents one of the most common urogenital abnormalities in childhood, affecting 1.1%-45% of preterm and 1%-4.6% of full-term infants, and approximately 10% of infertile males have a history of cryptorchidism.

Obtaining sperm by microdissection testicular sperm extraction (mTESE) is the primary treatment approach for males with NOA. The average sperm retrieval rate (SRR) in NOA males is approximately 50%, however, NOA patients with different etiologies have different SSRs ranging from 30% to 75%, with the highest and lowest SRRs corresponding to those with a history of mumps orchitis and iNOA, respectively. The predictive factors of SRR in males with NOA treated with mTESE include age; testis volume; serum follicle stimulating hormone (FSH), testosterone (T), inhibin B, and anti-Müllerian hormone (AMH) levels and testicular histopathology. However, the relationship between SSR and age in NOA patients undergoing mTESE is unclear, with several studies reporting no association between SSR and age or a negative correlation between SSR and age. Other studies have reported that older age was predictive of successful sperm retrieval.

The goal of this study was to analyze the factors influencing the SRR in NOA patients with different etiologies treated with mTESE based on age, body mass index (BMI), testis volume hormone levels and infertility duration in a large cohort. Our findings provide valuable information on the likelihood of successful mTESE. Therefore, preoperative evaluations based on the information provided in this study will help patients and surgeons in selecting the best approach by shared decision-making.

Conditions

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Non-obstructive Azoospermia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Obstructive azoospermia patients.
* Fertile males.
Minimum Eligible Age

21 Years

Maximum Eligible Age

57 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li Zhang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 28410062 (View on PubMed)

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.

Reference Type RESULT
PMID: 20609027 (View on PubMed)

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.

Reference Type RESULT
PMID: 12871878 (View on PubMed)

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.

Reference Type RESULT
PMID: 20664188 (View on PubMed)

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.

Reference Type RESULT
PMID: 21397198 (View on PubMed)

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.

Reference Type RESULT
PMID: 33390350 (View on PubMed)

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.

Reference Type RESULT
PMID: 20517181 (View on PubMed)

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.

Reference Type RESULT
PMID: 7782441 (View on PubMed)

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.

Reference Type RESULT
PMID: 32341210 (View on PubMed)

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.

Reference Type RESULT
PMID: 23062736 (View on PubMed)

Other Identifiers

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78070

Identifier Type: -

Identifier Source: org_study_id

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