Health TrialsbyHealthPanel

Linzagolix in Adenomyosis and Recurrent Implantation Failure

ConditionsAdenomyosis of UterusImplantation FailureInfertility FemaleEmbryo Transfer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorVida Fertility Institute

About this trial

Adenomyosis is associated with impaired endometrial receptivity and reduced implantation rates in assisted reproduction, even when using high-quality embryos. Linzagolix (Yselty, 200 mg) is an oral GnRH receptor antagonist approved for uterine fibroids with a favourable tolerability profile and rapid elimination half-life (18-20 hours) compared to GnRH agonists.

This prospective case series evaluates the efficacy of linzagolix 200 mg administered for 3 to 6 months prior to embryo transfer in patients with confirmed adenomyosis and recurrent implantation failure (RIF), defined as ≥2 failed transfers with high-quality blastocysts (≥BB Gardner in oocyte donation, or PGT-A confirmed euploid in autologous cycles).

The primary endpoint is the live birth rate (LBR) per embryo transfer. Secondary endpoints include clinical pregnancy rate, miscarriage rate, morphological response of adenomyosis (uterine volume and junctional zone \[JZ\] thickness assessed by standardised transvaginal ultrasound), and tolerability profile. The study also explores the optimal treatment duration (3 vs 6 months) as a sub-analysis based on morphological response at the month-3 visit.

The study is conducted at three centres of Vida Fertility Institute (Madrid, Alicante and San Sebastián, Spain). Sample size: n=35 patients. Study duration: 24 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Untreated hydrosalpinx

Untreated stage III-IV endometriosis

Major uterine anomaly (uterine septum, bicornuate uterus)

Known contraindication to linzagolix including known hepatopathy

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Linzagolix 200 mg (Yselty)

    Drug

    Linzagolix 200 mg orally once daily for a minimum of 3 months, extendable to 6 months based on morphological response (uterine volume and junctional zone assessment) at the month-3 transvaginal ultrasound visit. Off-label use for adenomyosis prior to embryo transfer.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Linzagolix 200 mg - Adenomyosis and RIF1 intervention

Trial outcomes

Primary outcomes

1

Live Birth Rate (LBR) per embryo transfer

Proportion of embryo transfers resulting in the birth of a live neonate at or beyond 24 weeks of gestation.

Time frame
Up to 12 months after embryo transfer

Secondary outcomes

1

Clinical Pregnancy Rate

Proportion of embryo transfers resulting in the presence of an intrauterine gestational sac with fetal heartbeat on transvaginal ultrasound at 6-7 weeks of gestation.

Time frame
6-7 weeks after embryo transfer
2

Miscarriage Rate

Proportion of clinical pregnancies ending in spontaneous pregnancy loss before 22 weeks of gestation.

Time frame
Up to 22 weeks of gestation
3

Change in Uterine Volume

Change in uterine volume (cm3) measured by transvaginal ultrasound using the ellipsoid formula (L x AP x T x 0.523) from baseline to post-treatment.

Time frame
Baseline, month 3, month 6 (if applicable) and pre-transfer (approximately 3-7 months from baseline)
4

Change in Junctional Zone Maximum Thickness

Change in junctional zone (JZ) maximum thickness (mm) measured by standardised transvaginal ultrasound in strict sagittal plane from baseline to post-treatment.

Time frame
Baseline, month 3, month 6 (if applicable) and pre-transfer (approximately 3-7 months from baseline)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vida Fertility Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: