Sperm Retrieval Rates in Non-obstructive Azoospermic Men Subjected to Gonadotropin Therapy
NCT ID: NCT05110391
Last Updated: 2022-11-03
Study Results
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Basic Information
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COMPLETED
616 participants
OBSERVATIONAL
2014-02-01
2021-09-15
Brief Summary
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Moreover, some investigators have hypothesized that the follicle-stimulating hormone (FSH) reset might increase the expression of FSH receptors and improve Sertoli cell function. Hormonal therapy with human chorionic gonadotropin (hCG) has been shown to improve ITT production and decrease FSH levels in patients with NOA. The investigators, therefore, designed an observational cohort study aiming to evaluate whether hormone stimulation with gonadotropins (e.g., hCG alone or combined with FSH) previous to micro-TESE increases sperm retrieval rates in hypogonadal infertile men with NOA, candidates for sperm retrieval. The investigators hypothesize that optimizing ITT production and resetting FSH levels may improve spermatogenesis and successful sperm recovery.
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Detailed Description
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The diagnosis of NOA was based on medical history, physical examination, semen analysis, reproductive hormone measurements, genetic and imaging studies, and confirmed by histopathology.
Hypogonadism was defined based on total testosterone levels equal to or below 350 ng/dL, measured on a peripheric blood specimen taken in the morning (8:00 to 10:00 am).
Sample size calculation:
Based on existing evidence concerning SRR in patients subjected to micro-TESE with and without medical treatment to boost testosterone production, the investigators estimated a sample size of 464 participants (232 per group) to have an 80% chance of detecting, as significant at the 5% level, an increase in the primary outcome measure from 41% in the control group to 55% in the experimental group.
Statistical Analysis:
Demographic data will include patient age, BMI, infertility cause, testicular volume, reproductive hormone levels, histopathology findings, infertility duration, presence of clinical varicocele, and history of varicocele repair. Treatment variables will include type, dose, and duration of gonadotropin administration, change in reproductive hormone levels pre- vs. post-treatment, and sperm retrieval outcomes.
Continuous data will be presented as median and 25-75% interquartile range. Categorical data will be described by the number of cases and percentages. As appropriate, categorical and continuous data will be analyzed using the Pearson Chi-square and Kruskal-Wallis or Wilcoxon test. Logistic regression analyses will be conducted to examine the association between demographic and treatment covariates and the binary response 'sperm retrieval success' (yes/no). Computations will be carried out using JMP® PRO 13 and SAS 9.3 (SAS Institute, Cary, North Carolina, USA).
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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NOA_Treated
Hypogonadal patients with non-obstructive azoospermia who received gonadotropin therapy before sperm retrieval
Hormonal Therapy Agent
Consecutive patients with NOA and hypogonadism (defined by baseline total testosterone levels equal or below 350 ng/dL) subjected to microdissection testicular sperm extraction who received or not pre-sperm retrieval gonadotropin therapy.
NOA_Untreated
Hypogonadal patients with non-obstructive azoospermia who did not receive gonadotropin therapy before sperm retrieval
No interventions assigned to this group
Interventions
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Hormonal Therapy Agent
Consecutive patients with NOA and hypogonadism (defined by baseline total testosterone levels equal or below 350 ng/dL) subjected to microdissection testicular sperm extraction who received or not pre-sperm retrieval gonadotropin therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Patients who had used any medication with known potential gonadotoxic effects six months before enrollment and patients under gonadotropin treatment who lost follow-up.
3. Patients with NOA due to hypogonadotropic hypogonadism.
4. Patients who had any number of sperm detected in the ejaculate by routine semen analysis with centrifugation before micro-TESE, including the analysis carried out on the surgery day. The latter relates to the fact that our study is designed to include only patients with NOA confirmed by histopathology, from a specimen obtained during micro-TESE.
5. NOA patients with baseline total testosterone levels above 350 ng/dL.
21 Years
55 Years
MALE
No
Sponsors
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ANDROFERT - Clinica de Andrologia e Reproducao Humana
OTHER
Responsible Party
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Sandro C. Esteves
Medical Director
Principal Investigators
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Sandro Esteves, MD., PhD.
Role: PRINCIPAL_INVESTIGATOR
ANDROFERT - Andrology and Human Reproduction Cente
Locations
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Androfert
Campinas, São Paulo, Brazil
Countries
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References
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Andrade DL, Viana MC, Esteves SC. Differential Diagnosis of Azoospermia in Men with Infertility. J Clin Med. 2021 Jul 16;10(14):3144. doi: 10.3390/jcm10143144.
Esteves SC, Prudencio C, Seol B, Verza S, Knoedler C, Agarwal A. Comparison of sperm retrieval and reproductive outcome in azoospermic men with testicular failure and obstructive azoospermia treated for infertility. Asian J Androl. 2014 Jul-Aug;16(4):602-6. doi: 10.4103/1008-682X.126015.
Hussein A, Ozgok Y, Ross L, Rao P, Niederberger C. Optimization of spermatogenesis-regulating hormones in patients with non-obstructive azoospermia and its impact on sperm retrieval: a multicentre study. BJU Int. 2013 Mar;111(3 Pt B):E110-4. doi: 10.1111/j.1464-410X.2012.11485.x. Epub 2012 Sep 7.
Reifsnyder JE, Ramasamy R, Husseini J, Schlegel PN. Role of optimizing testosterone before microdissection testicular sperm extraction in men with nonobstructive azoospermia. J Urol. 2012 Aug;188(2):532-6. doi: 10.1016/j.juro.2012.04.002. Epub 2012 Jun 15.
Achermann APP, Pereira TA, Esteves SC. Microdissection testicular sperm extraction (micro-TESE) in men with infertility due to nonobstructive azoospermia: summary of current literature. Int Urol Nephrol. 2021 Nov;53(11):2193-2210. doi: 10.1007/s11255-021-02979-4. Epub 2021 Aug 19.
Arshad MA, Majzoub A, Esteves SC. Predictors of surgical sperm retrieval in non-obstructive azoospermia: summary of current literature. Int Urol Nephrol. 2020 Nov;52(11):2015-2038. doi: 10.1007/s11255-020-02529-4. Epub 2020 Jun 9.
Laursen RJ, Elbaek HO, Povlsen BB, Lykkegaard J, Jensen KBS, Esteves SC, Humaidan P. Hormonal stimulation of spermatogenesis: a new way to treat the infertile male with non-obstructive azoospermia? Int Urol Nephrol. 2019 Mar;51(3):453-456. doi: 10.1007/s11255-019-02091-8. Epub 2019 Feb 11. No abstract available.
Esteves SC. Clinical management of infertile men with nonobstructive azoospermia. Asian J Androl. 2015 May-Jun;17(3):459-70. doi: 10.4103/1008-682X.148719.
Esteves SC. Microdissection testicular sperm extraction (micro-TESE) as a sperm acquisition method for men with nonobstructive azoospermia seeking fertility: operative and laboratory aspects. Int Braz J Urol. 2013 May-Jun;39(3):440; discussion 441. doi: 10.1590/S1677-5538.IBJU.2013.03.21.
Esteves SC, Agarwal A. Reproductive outcomes, including neonatal data, following sperm injection in men with obstructive and nonobstructive azoospermia: case series and systematic review. Clinics (Sao Paulo). 2013;68 Suppl 1(Suppl 1):141-50. doi: 10.6061/clinics/2013(sup01)16.
Tharakan T, Corona G, Foran D, Salonia A, Sofikitis N, Giwercman A, Krausz C, Yap T, Jayasena CN, Minhas S. Does hormonal therapy improve sperm retrieval rates in men with non-obstructive azoospermia: a systematic review and meta-analysis. Hum Reprod Update. 2022 Aug 25;28(5):609-628. doi: 10.1093/humupd/dmac016.
Esteves SC, Achermann APP, Miyaoka R, Verza S Jr, Fregonesi A, Riccetto CLZ. Clinical factors impacting microdissection testicular sperm extraction success in hypogonadal men with nonobstructive azoospermia. Fertil Steril. 2024 Oct;122(4):636-647. doi: 10.1016/j.fertnstert.2024.06.013. Epub 2024 Jun 22.
Other Identifiers
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ANDROFERT-03-20
Identifier Type: -
Identifier Source: org_study_id
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