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Mitochondrial DNA mutation may be a hidden cause of male infertility

NCT ID NCT07691827

Knowledge-focused Sponsor: The Third Affiliated Hospital of Guangzhou Medical University Source: ClinicalTrials.gov ↗

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Recruiting now This study
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Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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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 Results may not be published yet.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)

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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

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Status unknown
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First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study investigates whether a specific mitochondrial DNA variant (MT-ND1 m.3700G>A) is associated with severe male infertility, specifically conditions where sperm production is absent or extremely low. Researchers analyzed existing medical records and biological samples from affected men, their family members, and fertile controls to see if the variant is inherited from the mother and linked to infertility. No treatments or interventions were given; the goal is to better understand the genetic causes of these infertility conditions.

What this could mean

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

What this could lead to
If confirmed, this could point toward genetic screening or future therapies for some forms of male infertility.
What could go wrong
This is an observational study, not a treatment trial. The findings may not apply to other populations or explain all cases of infertility.

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.

Participants

About 1,200 people

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

Started

Apr 2021

Expected to finish

Jun 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.

Who is studied

Participants were selected from men receiving care at the Reproductive Medicine Center of the Third Affiliated Hospital of Guangzhou Medical University. The study population included men with idiopathic non-obstructive azoospermia or cryptozoospermia identified through clinical records and available biospecimens; men with normal spermatogenic function or obstructive azoospermia who served as comparison participants; and, when needed, available first-degree relatives and spouses for family-based genetic analyses. Testicular tissue was obtained only from residual specimens following clinically indicated testicular biopsy, TESA, or micro-TESE procedures.

Ages

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

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Men with idiopathic non-obstructive azoospermia or cryptozoospermia. * Male patients undergoing a clinically indicated testicular biopsy, testicular sperm aspiration (TESA), microdissection testicular sperm extraction (micro-TESE), or a related clinical procedure, when residual clinical specimens are available. * Comparison participants with normal spermatogenesis, including men with obstructive azoospermia and men undergoing sperm retrieval or testicular tissue evaluation for clinical reasons. * Selected relatives and spouses of enrolled patients, when needed for genetic segregation analysis and determination of variant origin. Exclusion Criteria: * For the idiopathic non-obstructive azoospermia or cryptozoospermia cohort, azoospermia with an established alternative cause, including chromosomal abnormalities, Y-chromosome microdeletions, testicular tumors, severe trauma, prior radiotherapy or chemotherapy, or confirmed infection. * Incomplete clinical data or inability to obtain informed consent. * Biospecimens that do not meet quality requirements for the planned analyses.

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Conditions

The condition(s) this trial relates to.

azoospermia male infertility oligospermia spermatogenic failure 3 spermatogenic failure, Y-linked, 2

As listed by the trial registrant

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

Azoospermia, nonobstructive Cryptozoospermia

How to take part

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  1. The places running it

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  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

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Contacts and locations

Locations

  • The Third Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, 510150, China

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