Gonadotropin Therapy Trial for Azoospermia
Summary
The NIH has registered a new clinical trial (NCT07540611) under the APHRODITE Group to evaluate whether short-term gonadotropin therapy (hCG + FSH) can increase sperm availability for ICSI in men with idiopathic non-obstructive azoospermia and hypogonadism. The randomized controlled trial will compare hormonal optimization with standard-of-care and assess outcomes including sperm retrieval success and reliance on micro-TESE through Week 16.
What changed
NIH has registered a new clinical trial on ClinicalTrials.gov for a randomized controlled study evaluating gonadotropin therapy (hCG + FSH) in men with idiopathic non-obstructive azoospermia and hypogonadism. The trial will compare hormonal therapy against standard-of-care with primary endpoints at Week 16 including sperm retrieval success via ejaculate or micro-TESE and embryological outcomes.
Clinical trial sponsors and investigators conducting reproductive medicine research should be aware of this registered study as it may inform future clinical practice regarding hormonal optimization prior to assisted reproduction. The trial design follows a standard randomized protocol with safety follow-up through Week 16.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Gonadotropin Therapy in Idiopathic Hypogonadal Non-Obstructive
N/A NCT07540611 Kind: NA Apr 20, 2026
Abstract
The goal of this clinical trial is to determine whether short-term gonadotropin therapy (hCG + FSH) can increase sperm availability for ICSI in men with idiopathic non-obstructive azoospermia (NOA) and hypogonadism. The main questions it aims to answer are:
Does hormonal optimization improve the likelihood of obtaining usable sperm (via ejaculate or micro-TESE) by Week 16? Does hormonal therapy reduce the need for micro-TESE or improve downstream embryological and clinical outcomes?
Because there is a comparison group, researchers will compare hCG + FSH hormonal therapy with standard-of-care (no gonadotropins) to see if hormonal optimization increases sperm retrieval success and decreases surgical reliance.
Participants will:
Undergo baseline hormonal and semen testing Be randomized to either hormonal therapy or standard-of-care If in the hormonal arm: receive hCG and FSH with monthly dose titration and aromatase inhibitors if indicated Provide semen samples at Weeks 12 and 16 Undergo micro-TESE if no ejaculated sperm are found (timing per protocol) Complete safety assessments and follow-up through Week 16
Conditions: APHRODITE Group
Interventions: No intervention, hCG + FSH therapy
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