Linzagolix in Adenomyosis and Recurrent Implantation Failure

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Conditions studied: Adenomyosis of Uterus, Implantation Failure, Infertility Female, Embryo Transfer

In brief

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.

Key facts

Study ID

NCT07698561

Run by

Vida Fertility Institute

People needed

35

Starts

2026-09-01

Expected to finish

2028-09-01

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Vida Fertility Alicante — Alicante, Alicante, Spain
• Vida Fertility Donostia — San Sebastián, Gipuzkoa, Spain
• Vida Fertility Institute Madrid — Madrid, Madrid, Spain

Full record on ClinicalTrials.gov

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