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Hormone shots may help infertile men avoid surgery

NCT ID NCT07540611

Disease control Sponsor: Indira IVF Hospital Pvt Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving men with low testosterone and no sperm in their ejaculate a combination of two hormones (hCG and FSH) can help them produce usable sperm for IVF. About 860 men will either receive the hormone therapy or standard care for 16 weeks. The goal is to see if the treatment increases the chance of finding sperm, either in the ejaculate or through a minor surgical procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hCG (human chorionic gonadotropin) and FSH (follicle-stimulating hormone) injections, plus optional aromatase inhibitors (anastrozole or letrozole)
What this could lead to
If it works, this could offer a non-surgical way to obtain sperm for IVF in men with low testosterone and no sperm in their ejaculate.
What could go wrong
This is an early-stage trial with 860 participants, and the treatment may not increase sperm production. Hormone therapy can cause side effects like mood changes or injection-site reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 860 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

azoospermia hypogonadism male infertility

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aphrodite group

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Recruitment

    Patna, Bihar, 800014, India

  • Recruitment

    Bangalore, Karnataka, 560041, 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

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