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IVF Needle-Free? oral pill tested as injection alternative

NCT ID NCT07732348

Disease control Sponsor: Centro A.M.B.R.A. (Associazione Medici e Biologi per la Riproduzione Assistita) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This trial tests whether an oral medication called linzagolix can replace daily injections used to prevent premature ovulation during in vitro fertilization (IVF). The study compares the number of mature eggs retrieved in women taking the pill versus those receiving standard injectable drugs. A separate group using a different hormonal protocol is also included for comparison. The goal is to see if the oral option works just as well while being easier to take.

What this could mean

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

Active substance
an oral GnRH antagonist called linzagolix, compared with injectable GnRH antagonists (ganirelix or cetrorelix)
What this could lead to
If it works, this could offer women undergoing IVF a simpler, needle-free option to prevent premature ovulation, potentially reducing stress and discomfort.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not be conclusive. Linzagolix is not yet approved for this use, and its effectiveness and safety in IVF are unproven.

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 195 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

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

Women presenting for a fresh IVF/ICSI cycle with controlled ovarian stimulation at CENTRO AMBRA, a single assisted reproduction center in Palermo, Italy. The population reflects the center's routine IVF/ICSI caseload during the enrollment period and is not selected by ovarian reserve: normal, poor, and high responders are all included, classified by age, AMH, and antral follicle count at baseline.

Ages

18 to 42 years

Sex

Female 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: * Female, aged 18 to 42 years * Indication for IVF/ICSI with controlled ovarian stimulation at CENTRO AMBRA * Population unselected for ovarian reserve (normal, poor, and high responders are eligible) * Written informed consent, including consent for off-label use of linzagolix and for data processing * For the two antagonist arms (Linzagolix and Injectable GnRH Antagonist): acceptance of randomization Exclusion Criteria: * Known contraindications or hypersensitivity to the study drugs * Uterine pathology relevant to the study outcome (e.g., uterine malformations, significant submucosal fibroids) * Contraindications to pregnancy or to ovarian stimulation * Concurrent participation in another interfering interventional study

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Conditions

The condition(s) this trial relates to.

female infertility

As listed by the trial registrant

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

Infertility, female Ovulation induction

How to take part

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

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. 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.

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