CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 616 enrolled
Drug / intervention
Hormonal Therapy Agentdrug
Likely dose
Not stated in record
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Search/NCT05110391
NCT05110391N/ACompleted

Sperm Retrieval Rates by Microdissection Testicular Sperm Extraction in Non-obstructive Azoospermic Men Subjected to Gonadotropin Therapy

ANDROFERT - Clinica de Andrologia e Reproducao Humana·observational·Posted Nov 8, 2021·Updated Nov 3, 2022

In Brief

An observational study evaluating Hormonal Therapy Agent for Non-obstructive Azoospermia and 3 related conditions. Completed, enrolled 616 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 8, 2021
Enrollment StartFeb 1, 2014
Primary CompletionSep 15, 2021
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 4.6 years ago

Interventions

Hormonal Therapy Agentdrug

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.