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Could a fibroid drug help women with adenomyosis finally achieve a live birth?

NCT ID NCT07698561

Disease control Sponsor: Vida Fertility Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study tests whether taking linzagolix (Yselty) for 3 to 6 months before an embryo transfer can improve live birth rates in women with adenomyosis who have experienced repeated implantation failure. Adenomyosis can make the womb lining less receptive to embryos, even when the embryos are high-quality. The trial will follow 35 women across three fertility clinics in Spain, measuring pregnancy and live birth outcomes, as well as changes in the womb's structure.

What this could mean

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

Active substance
linzagolix (Yselty)
What this could lead to
If successful, this could offer a new pre-treatment option to improve pregnancy and live birth rates in women with adenomyosis who have repeatedly failed embryo transfers.
What could go wrong
This is a small, early-phase study with only 35 participants, so results may not apply broadly. Linzagolix is used off-label here, and its benefits for adenomyosis prior to embryo transfer are not yet proven.

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 35 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

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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 aged 18 to 50 years with confirmed adenomyosis (transvaginal ultrasound or MRI) and recurrent implantation failure, defined as 2 or more failed embryo transfers with high-quality blastocysts (grade BB or above in oocyte donation cycles, or PGT-A confirmed euploid blastocysts in autologous cycles), attending Vida Fertility Institute centres in Madrid, Alicante and San Sebastian, Spain.

Ages

18 to 50 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: * Age 18 to 50 years * Confirmed adenomyosis by transvaginal ultrasound or MRI * Recurrent implantation failure defined as 2 or more failed embryo transfers with high-quality blastocysts: oocyte donation recipients (blastocyst grade BB or above, Gardner classification) OR autologous IVF cycles with PGT-A confirmed euploid blastocysts * Normal uterine cavity with no submucosal distortion * At least 1 suitable embryo available for transfer (blastocyst grade BB or above, or PGT-A euploid) * Signed written informed consent including explicit acknowledgement of off-label use of linzagolix Exclusion Criteria: * Untreated hydrosalpinx * Untreated stage III-IV endometriosis * Major uterine anomaly (uterine septum, bicornuate uterus) * Known contraindication to linzagolix including known hepatopathy * Prior treatment with linzagolix * GnRH analogue treatment within 6 months prior to enrolment * BMI greater than 35 kg/m2 * Prior failed transfers exclusively with embryos below the quality threshold (below BB grade, non-euploid)

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Conditions

The condition(s) this trial relates to.

adenomyosis female infertility

As listed by the trial registrant

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

Adenomyosis of uterus Embryo transfer Implantation failure Infertility, female

How to take part

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

  1. The places running it

    3 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

  • Vida Fertility Alicante

    Alicante, Alicante, 03008, Spain

  • Vida Fertility Donostia

    San Sebastián, Gipuzkoa, 20018, Spain

  • Vida Fertility Institute Madrid

    Madrid, Madrid, 28043, Spain

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