Clinical Trial

Gonadotropin Therapy in Idiopathic Hypogonadal Non-Obstructive

Study acronym: GTIHNO
Not Yet Recruiting
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Summary
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
Trial Details
NCT Number NCT07540611
Lead Sponsor Indira IVF Hospital Pvt Ltd
Conditions APHRODITE Group
Enrollment 860 participants
Start Date 2026-07-17
Primary Completion 2027-01-16 (estimated)
Study Completion 2027-07-17 (estimated)
Updated on ClinicalTrials.gov 2026-04-20