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Not yet recruiting Not applicable NCT07540611

Gonadotropin Therapy in Idiopathic Hypogonadal Non-Obstructive

No applicable phase (e.g. observational)
Conditions: APHRODITE Group

Sponsor: Indira IVF Hospital Pvt Ltd

trial.available_in: БГ
Overview
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
Who can participate
Inclusion Criteria: \- Idiopathic NOA; hypogonadal (TT \<350 ng/dL on two fasting morning tests); FSH ≥7.6 IU/L (APHRODITE Group 3: 7.6-12.0 IU/L; Group 4: \>12.0 IU/L). Exclusion Criteria: cryptorchidism, chemo/radiation, genetic NOA (e.g., AZFa/complete AZFb), testicular trauma/torsion, post-orchitis. prior micro-TESE within 12 months; recent gonadotropin therapy (\<6 months); uncontrolled endocrine disease; active malignancy; severe liver disease; polycythemia (Hct\>50%); inability to comply. Varicocele\>= Grade 3
Interventions
No intervention
OTHER
hCG + FSH therapy
OTHER
Locations 8
India (8)
Recruitment
Allahābād , Uttar Pradesh
Recruitment
Bangalore , Karnataka
Recruitment
Bhāndup , Maharashtra
Rinoy Shreedharan, MD
Recruitment
Delhi , National Capital Territory of Delhi
Recruitment
Jaipur , Rajasthan
Recruitment
Lucknow , Uttar Pradesh
Recruitment
Patna , Bihar
Dayaniddhi Kumar, Ph D
Recruitment
Pune , Maharashtra
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male only
Healthy volunteers
No
Start date
17.07.2026
Completion date
17.07.2027
Registry ID
NCT07540611
Source
clinicaltrials.gov
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