Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07540611

Gonadotropin Therapy in Idiopathic Hypogonadal Non-Obstructive

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

APHRODITE Group Endocrine System Diseases Genital Diseases Genital Diseases, Male Gonadal Disorders Hypogonadism Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Recruitment, Patna, Bihar, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. Success or Sperm Availability

    Time frame: 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.

Secondary outcomes

  1. Micro-TESE Sperm Retrieval Rate (SSR)

    Time frame: 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-

    Whether sperm are retrieved during micro-TESE

  2. Need for Micro-TESE Surgery

    Time frame: Up to Week 16

    Whether the participant requires micro-TESE

  3. Safety / Harms

    Time frame: Week 16

    All adverse events (AE/SAE) related to treatment or procedure

  4. ICSI Fertilization Rate

    Time frame: Within the ICSI cycle ≈ Day 1-3 after ICSI

    % of injected oocytes that form normal 2PN embryos

  5. Blastulation Rate

    Time frame: Day 5-7 after fertilization

    % of embryos reaching blastocyst stage

  6. Blastocyst Quality

    Time frame: Day 5-7 after fertilization

    Grading of blastocysts based on standard morphology criteria

  7. Top-Quality Blastocyst Rate

    Time frame: Day 5-7 after fertilization

    % of "top-1 quality" blastocysts formed

  8. Clinical Pregnancy Rate

    Time frame: ≈ 6-8 weeks after embryo transfer

    Presence of gestational sac with cardiac activity on ultrasound

  9. Miscarriage Rate

    Time frame: From pregnancy confirmation to 20 weeks gestation

    Pregnancy loss before 20 weeks

  10. Live Birth

    Time frame: Up to delivery (~9 months after embryo transfer)

    Delivery of a live infant

Study contacts

Contact information is provided by the study sponsor or research team.

Vipin Chandra, DGO

CONTACT

[email protected]

9567971239

Sponsors and collaborators

Lead sponsor

Indira IVF Hospital Pvt Ltd

Other

Registry information

Official study title

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

Acronym: GTIHNO

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 20, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.