Gonadotropin Therapy in Idiopathic Hypogonadal Non-Obstructive

Starting soon · Not applicable

Conditions studied: APHRODITE Group

In brief

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

Key facts

Study ID

NCT07540611

Run by

Indira IVF Hospital Pvt Ltd

People needed

860

Starts

2026-07-17

Expected to finish

2027-07-17

Last updated by the study team

2026-04-20

Who can join

Age: any. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Recruitment — Patna, Bihar, India
• Recruitment — Bangalore, Karnataka, India
• Recruitment — Bhāndup, Maharashtra, India
• Recruitment — Pune, Maharashtra, India
• Recruitment — Delhi, National Capital Territory of Delhi, India
• Recruitment — Jaipur, Rajasthan, India
• Recruitment — Allahābād, Uttar Pradesh, India
• Recruitment — Lucknow, Uttar Pradesh, India

Full record on ClinicalTrials.gov

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