Health TrialsbyHealthPanel

Gonadotropin Therapy in Idiopathic Hypogonadal Non-Obstructive

ConditionAPHRODITE Group
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorIndira IVF Hospital Pvt Ltd

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • No intervention

    Other intervention

    Standard of Care

  • hCG + FSH therapy

    Other intervention

    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

Treatment groups

860 Participants
are divided into 2 treatment groups
Group A: hCG + FSH therapyExperimental treatment 1 intervention
Group B: Standard of CareActive comparator 1 intervention

Trial outcomes

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.

Time frame
from randomization through Week 16 via ejaculate or micro-TESE

Secondary outcomes

1

Micro-TESE Sperm Retrieval Rate (SSR)

Whether sperm are retrieved during micro-TESE

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-
2

Need for Micro-TESE Surgery

Whether the participant requires micro-TESE

Time frame
Up to Week 16
3

Safety / Harms

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

Time frame
Week 16
4

ICSI Fertilization Rate

% of injected oocytes that form normal 2PN embryos

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indira IVF Hospital Pvt Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: