Linzagolix in Adenomyosis and Recurrent Implantation Failure

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

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 design

Treatments tested in this trial

  • Linzagolix 200 mg (Yselty)

Treatment groups

35 Participants
are divided into 1 treatment group

Sponsors and collaborators