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Studies

Interventional Not yet recruiting

NCT07540611 on ClinicalTrials.gov

Gonadotropin Therapy in Idiopathic Hypogonadal Non-Obstructive

Official title: "Gonadotropin Therapy in Idiopathic Hypogonadal Non-Obstructive Azoospermia (APHRODITE Groups 3-4): A Multicenter Randomized Controlled Trial"

  • Sponsor: Indira IVF Hospital Pvt Ltd
  • Enrollment: 860 (Estimated)
  • Study start: 2026-07-17 (Estimated)
  • Primary completion: 2027-01-16 (Estimated)
  • Study completion: 2027-07-17 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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

Conditions

  • APHRODITE Group

Intervention / Treatment

  • Other: No intervention
  • Other: hCG + FSH therapy

Primary Outcome Measures

  • Success or Sperm Availability (from randomization through Week 16 via ejaculate or micro-TESE)
    Sperm Availability for ICSI was defined as the presence of viable sperm suitable for intracytoplasmic sperm injection (ICSI) at any time from randomization through Week 16. Sperm could be obtained either through ejaculate or via microsurgical testicular sperm extraction (micro-TESE). Assessment of sperm availability was performed by a centralized adjudication committee, which was blinded to treatment allocation to ensure objective and unbiased evaluation.

Countries

India

Locations and Investigators

  • Recruitment, Patna, India
    • Dayaniddhi Kumar, Ph D
  • Recruitment, Bangalore, India
    • Shyam Gupta, MD
  • Recruitment, Bhāndup, India
    • Rinoy Shreedharan, MD
  • Recruitment, Pune, India
    • Amol Lunkad, MD
  • Recruitment, Delhi, India
  • Recruitment, Jaipur, India
    • Tanu Batra, MD
  • Recruitment, Allahābād, India
    • Anjali Gahlan, MS
  • Recruitment, Lucknow, India
    • Pawan Yadav, MD