Gonadotropin Therapy in Idiopathic Hypogonadal Non-Obstructive

NCT07540611 | Not Yet Recruiting DMC

• 1 other identifier: IIHL-UDR-P-002-2025
• Study Type: interventional
• Target: 860
• Locations: 1 country
• Sites: 8

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

Keywords

Non-obstructive azoospermia (NOA); Idiopathic NOA; Male infertility; Hypogonadism

Outcome Measures

Primary Outcomes (1)

• Success or Sperm Availability

  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.

  from randomization through Week 16 via ejaculate or micro-TESE

Secondary Outcomes (10)

• Micro-TESE Sperm Retrieval Rate (SSR)

  The Micro-TESE Sperm Retrieval Rate (SSR) was assessed during the period from randomization through Week 16. The outcome was determined based on the availability of at least one viable sperm retrieved via microsurgical testicular sperm extraction (micro-

• Need for Micro-TESE Surgery

  Up to Week 16

• Safety / Harms

  Week 16

• ICSI Fertilization Rate

  Within the ICSI cycle ≈ Day 1-3 after ICSI

• Blastulation Rate

  Day 5-7 after fertilization

Study Arms (2)

hCG + FSH therapy

EXPERIMENTAL

Other: hCG + FSH therapy

Standard of Care

ACTIVE COMPARATOR

Other: No intervention

Interventions

No intervention OTHER

Standard of Care

Standard of Care

hCG + FSH therapy OTHER

hCG + FSH therapy with monthly hormone-driven titration (hCG initial \~83 µg SC twice weekly; no preset min/max; target TT \>350-900 ng/dL) + FSH 150 IU SC twice weekly (increase to 150 IU SC three times weekly if 'FSH reset' \<1.5 IU/L); allow anastrozole 1 mg PO daily /letrozole 2.5 mg half tablet alternate day if T/E \<10

hCG + FSH therapy

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Indira IVF Hospital Pvt Ltd: lead

Study Sites (8)

Recruitment

Patna, Bihar, 800014, India

Location

Recruitment

Bangalore, Karnataka, 560041, India

Location

Recruitment

Bhāndup, Maharashtra, India

Location

Recruitment

Pune, Maharashtra, India

Location

Recruitment

Delhi, National Capital Territory of Delhi, India

Location

Recruitment

Jaipur, Rajasthan, India

Location

Recruitment

Allahābād, Uttar Pradesh, India

Location

Recruitment

Lucknow, Uttar Pradesh, India

Location

Related Publications (2)

• Esteves SC, Yarali H, Vuong LN, Carvalho JF, Ozbek IY, Polat M, Le HL, Pham TD, Ho TM. Low Prognosis by the POSEIDON Criteria in Women Undergoing Assisted Reproductive Technology: A Multicenter and Multinational Prevalence Study of Over 13,000 Patients. Front Endocrinol (Lausanne). 2021 Mar 12;12:630550. doi: 10.3389/fendo.2021.630550. eCollection 2021.

  PMID: 33790862 RESULT

• Esteves SC, Humaidan P, Ubaldi FM, Alviggi C, Antonio L, Barratt CLR, Behre HM, Jorgensen N, Pacey AA, Simoni M, Santi D. APHRODITE criteria: addressing male patients with hypogonadism and/or infertility owing to altered idiopathic testicular function. Reprod Biomed Online. 2024 Apr;48(4):103647. doi: 10.1016/j.rbmo.2023.103647. Epub 2023 Oct 29.

  PMID: 38367592 RESULT

MeSH Terms

Conditions

Infertility, Male; Hypogonadism

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases; Gonadal Disorders; Endocrine System Diseases

Central Study Contacts

Vipin Chandra, DGO

CONTACT

9567971239; drvipinchandra@indiraivf.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Clinical Lab Operations

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: April 20, 2026
• Study Start (Estimated): July 17, 2026
• Primary Completion (Estimated): January 16, 2027
• Study Completion (Estimated): July 17, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

IN (8)