Non-obstructive AzoospermiaNCT05958576
Effect of Age on Sperm Recovery of Microdissection Testicular Sperm Extraction in Nonobstructive Azoospermia Patients
An observational study of Non-obstructive Azoospermia, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 57 years, men only
- Conditions the study is for
- Non-obstructive Azoospermia
- How many people
- 3,104 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2012to 31 Mar 2023
- Phase
- Observational
- 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 21 to 57 years
- Men only
- No healthy volunteers
- Adult
Study population: Non-obstructive azoospermia patients
Who may be able to join
- Non-obstructive azoospermia patients were treated with microdissection testicular sperm extraction.
Who cannot join
- Obstructive azoospermia patients.
- Fertile males.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
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.
Read the detailed description
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
- Non-obstructive Azoospermia
- Keywords
- non-obstructive azoospermia, microdissection testicular sperm extraction, sperm retrieval rate, age
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start1 Mar 2012
- Primary completion31 Dec 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Non-obstructive AzoospermiaStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Zhang, Ph.D, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958576
- Sponsor's protocol ID
- 78070
- Status last verified
- Dec 2022
- First submitted
- 15 Jul 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Publications
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.
PubMed 28410062Tuttelmann 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.
PubMed 20609027Hopps 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.
PubMed 12871878Forti 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.
PubMed 20664188Krausz 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.
PubMed 21397198Pena 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.
PubMed 33390350Ternavasio-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.
PubMed 20517181Mieusset 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.
PubMed 7782441Zhang 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.
PubMed 32341210Bonarriba 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.
PubMed 23062736
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Age on Sperm Recovery of Microdissection Testicular Sperm Extraction in Nonobstructive Azoospermia Patients
- ClinicalTrials.gov ID
- NCT05958576
- Acronym / sponsor ID
- 78070
- Conditions
- Non-obstructive Azoospermia
- Keywords
- non-obstructive azoospermia, microdissection testicular sperm extraction, sperm retrieval rate, age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,104 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Mar 2012 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 21 to 57 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Non-obstructive azoospermia patients
Key inclusion criteria (1 listed)
- Non-obstructive azoospermia patients were treated with microdissection testicular sperm extraction.
Key exclusion criteria (2 listed)
- Obstructive azoospermia patients.
- Fertile males.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sperm retrieval rate
Time frame: immediately after surgery
If sperm was observed during the surgery, this case was defined as positive. If sperm wasn't observed, the case was defined as negative.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Results publication: PubMed 28410062Mittal 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.
- Results publication: PubMed 20609027Tuttelmann 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.
- Results publication: PubMed 12871878Hopps 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.
- Results publication: PubMed 20664188Forti 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.
- Results publication: PubMed 21397198Krausz 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.
- Results publication: PubMed 33390350Pena 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.
- Results publication: PubMed 20517181Ternavasio-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.
- Results publication: PubMed 7782441Mieusset 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.
- Results publication: PubMed 32341210Zhang 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.
- Results publication: PubMed 23062736Bonarriba 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.
- Individual participant dataSharing planned: No. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Zhang, Ph.D principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-obstructive Azoospermia, run by Peking University Third Hospital at 1 site in China.
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 1 inclusion and 2 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 24 Jul 2023. 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 China. 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?
sperm retrieval rate (time frame: immediately after surgery). 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 NCT05958576, which also lists 10 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 24 Jul 2023.