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Heart drug warfarin under scrutiny for male fertility risks

NCT ID NCT07330869

Knowledge-focused Sponsor: Città di Lecce Hospital, GVM Care & Research 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study will follow 90 men aged 18-50 who need heart surgery, some of whom will take the blood thinner warfarin afterward. Researchers will track changes in sperm count, movement, shape, DNA health, and hormone levels over 12 months. The goal is to see if warfarin harms male fertility, which could help doctors better counsel patients about family planning.

What this could mean

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

Active substance
warfarin
What this could lead to
If this study finds a link, it could lead to better counseling and fertility preservation for young men needing warfarin after heart surgery.
What could go wrong
This is a small pilot study, not a treatment trial. It only observes possible effects and cannot prove cause. Results may not apply to all men.

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 90 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

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

This study will enroll male patients aged 18 to 50 years undergoing elective cardiac surgery at a high-volume cardiac surgery center. Participants will include individuals requiring either lifelong Warfarin therapy (mechanical heart valve replacement), short-term postoperative Warfarin therapy (e.g., mitral valve repair or bioprosthetic valve implantation), or no long-term anticoagulation beyond routine perioperative prophylaxis. Eligible patients must have no previous diagnosis of male infertility, must be able and willing to provide semen samples at scheduled follow-up timepoints, and must provide written informed consent. Patients with severe testicular disease, prior chemotherapy or radiotherapy, endocrine disorders affecting spermatogenesis, active genitourinary infection, or current/recent use of anabolic steroids or medications known to impair spermatogenesis will be excluded.

Ages

18 to 50 years

Sex

Male participants only

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: * Male sex, age between 18 and 50 years; * Scheduled for elective cardiac surgery (valve replacement, valve repair, or other cardiac procedures) with or without indication to Warfarin therapy; * Ability and willingness to provide semen samples at scheduled timepoints; * No previous diagnosis of male infertility documented in medical records; * Signed informed consent. Exclusion Criteria: * Known severe testicular pathology (for example, untreated high-grade varicocele, history of cryptorchidism, orchiectomy, testicular tumors); * Prior chemotherapy or pelvic radiotherapy; * Current or recent use of anabolic steroids or other drugs known to strongly impair spermatogenesis; * Known endocrine disorders affecting spermatogenesis (for example, untreated hypogonadism, hyperprolactinaemia, severe thyroid disease); * Active genitourinary infection at the time of evaluation; * Life expectancy less than 12 months or clinical conditions preventing adherence to follow-up.

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Conditions

The condition(s) this trial relates to.

heart valve disorder Inflammation male infertility

As listed by the trial registrant

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

Heart valve disease Male infertility

How to take part

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

  1. The places running it

    1 site. 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

  • Città di Lecce Hospital - Department of Cardiac Surgery

    Lecce, LE, 73100, Italy

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