An observational study in Non-obstructive Azoospermia, Hormone Deficiency and Hypogonadism, Male, sponsored by ANDROFERT - Clinica de Andrologia e Reproducao Humana. Completed at 1 site in Brazil. Open to male participants aged 21 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-11-03.
Sponsored by ANDROFERT - Clinica de Andrologia e Reproducao Humana · Observational
Azoospermia is defined as the complete absence of spermatozoa in the ejaculate. Two-thirds of azoospermic patients have non-obstructive azoospermia (NOA); the latter comprises up to 10% of infertile men overall. NOA is an untreatable testicular disorder associated with spermatogenic failure and is the most severe male infertility phenotype. Among the available surgical sperm retrieval techniques, microdissection testicular sperm extraction (micro-TESE) is the procedure of choice due to its high sperm retrieval success rates (SRR), minimal tissue extraction, and low complication rates. Even with the use of micro-TESE, the likelihood of retrieving sperm in patients with NOA remain suboptimal (40% to 60%). Hypogonadism is detected in approximately half of the patients with NOA. Given the role of intratesticular testosterone (ITT) levels for spermatogenesis, some studies have explored the clinical utility of testosterone optimization by medical therapy before sperm retrieval.
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.
A single-center cohort study was conducted based on prospectively collected data inputted in an electronic medical record database, subsequently extracted and analyzed.
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).
75 studies on the registry are indexed under Eunuchism; 21 are open to participants now.
This study's enrollment of 616 is above the median of 100 across 17 observational studies indexed under Eunuchism.
Browse Eunuchism studies →ANDROFERT - Clinica de Andrologia e Reproducao Humana is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Hypogonadal patients with non-obstructive azoospermia seeking fertility.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypogonadal patients with non-obstructive azoospermia who received gonadotropin therapy before sperm retrieval
Drug: Hormonal Therapy Agent
Hypogonadal patients with non-obstructive azoospermia who did not receive gonadotropin therapy before sperm retrieval
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.
Also known as: recombinant human chorionic gonadotropin, recombinant FSH
Sperm retrieval rates
Sperm retrieval success rates by micro-TESE in men with non-obstructive azoospermia subjected or not to pre-operative hormonal stimulation
Time frame: At least 3 months
Sperm retrieval rates according to hypogonadism status
Sperm retrieval success rates by micro-TESE in men with non-obstructive azoospermia subjected or not to pre-operative hormonal stimulation, according to hypogonadism categories based on baseline total testosterone levels
Time frame: At least 3 months
Sperm retrieval rates according to histopathology findings
Sperm retrieval success rates by micro-TESE in men with non-obstructive azoospermia subjected or not to pre-operative hormonal stimulation, according to testis biopsy histopathology findings
Time frame: At least 3 months
Predictive factors for sperm retrieval success
Assessment of independent co-variables affecting the binary response sperm retrieval (yes/no)
Time frame: At least 3 months
Plan to share: Undecided
Ran from Feb 2014 to primary completion in Sep 2021, 91 months.
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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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ANDROFERT - Clinica de Andrologia e Reproducao Humana