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Trial · Observational

CompletedPhase not statedRegistry data

Sperm Retrieval Rates in Non-obstructive Azoospermic Men Subjected to Gonadotropin Therapy

NCTNCT05110391 (opens ClinicalTrials.gov in a new tab)Other idANDROFERT-03-20
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
616 participants (actual)
Sponsor
ANDROFERT - Clinica de Andrologia e Reproducao Humana · Other
Design
Not stated
Countries
1 country

Brazil

Start
1 Feb 2014
Primary completion
15 Sept 2021
Completion
15 Sept 2021
First posted
8 Nov 2021
Last update posted
3 Nov 2022
Conditions
Non-obstructive Azoospermia · Hormone Deficiency · Hypogonadism, Male · Male Infertility

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142016201820202022
  1. Ph –

    Sperm Retrieval Rates in Non-obstructive Azoospermic Men Subjected to Gonadotropin Therapy

    NCT05110391

    1 Feb 2014 to 15 Sept 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Hormonal Therapy AgentDrug

Arms2

  • Other

    NOA_Treated

    Hypogonadal patients with non-obstructive azoospermia who received gonadotropin therapy before sperm retrieval

  • Other

    NOA_Untreated

    Hypogonadal patients with non-obstructive azoospermia who did not receive gonadotropin therapy before sperm retrieval

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Sperm retrieval rates

    Time frame · At least 3 months

    Registry description

    Sperm retrieval success rates by micro-TESE in men with non-obstructive azoospermia subjected or not to pre-operative hormonal stimulation

Secondary outcomes(3)

  1. Sperm retrieval rates according to hypogonadism status

    Time frame · At least 3 months

    Registry description

    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

  2. Sperm retrieval rates according to histopathology findings

    Time frame · At least 3 months

    Registry description

    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

  3. Predictive factors for sperm retrieval success

    Time frame · At least 3 months

    Registry description

    Assessment of independent co-variables affecting the binary response sperm retrieval (yes/no)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

PubMed tag: none · 2013

7 results

Optimization of spermatogenesis-regulating hormones in patients with non-obstructive azoospermia and its impact on sperm retrieval: a multicentre study.

Hussein et al. 2013BJU internationalcited by 98

PMID 22958644DOI 10.1111/j.1464-410x.2012.11485.xPUB-22958644

Rights unknown7 results
Source linkSee results (7)

PubMed tag: none · 2012

4 results

Role of optimizing testosterone before microdissection testicular sperm extraction in men with nonobstructive azoospermia.

Reifsnyder et al. 2012The Journal of urologycited by 93

PMID 22704105DOI 10.1016/j.juro.2012.04.002PUB-22704105

Full text at the publisher4 results
Publisher pageSee results (4)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedEsteves 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. PMID 38909671

Eligibility

Who could join, as posted.

Sex
Male
Age
from 21 Years up to 55 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Consecutive NOA patients with a baseline total testosterone level equal to or below 350 ng/dL who had a sperm retrieval procedure by microdissection testicular sperm extraction (micro-TESE) during the study period. Only patients with histopathology-confirmed NOA, absence of Y-chromosome microdeletion in the azoospermia factor 'a' (AZFa) and/or azoospermia factor 'b' (AZFB) region, and with a complete data record for analysis of primary and secondary outcomes were included. Exclusion Criteria: 1. Patients subjected to sperm retrieval using percutaneous or non-microsurgical testicular biopsies and those with a history of a previous sperm retrieval attempt. 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.

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