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Linzagolix in Adenomyosis and Recurrent Implantation Failure (LINZA-RIF)

2026年7月6日 更新者：Vida Fertility Institute

Efficacy of Linzagolix 200 mg for 3 to 6 Months Prior to Embryo Transfer in Patients With Adenomyosis and Recurrent Implantation Failure: A Prospective Case Series

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

BACKGROUND:

Current standard of care for adenomyosis prior to embryo transfer in RIF patients consists of GnRH agonist therapy (triptorelin depot) for 1-3 months, with or without letrozole. This approach requires intramuscular administration, is associated with intense vasomotor symptoms, and has a prolonged pharmacological residual effect (4-6 weeks) that complicates cycle planning. No prospective study has evaluated linzagolix in this specific clinical scenario.

DESIGN:

Prospective before-after case series. Each patient serves as her own historical control (prior failed transfers under standard care vs outcome after linzagolix treatment). Treatment duration (3 or 6 months) is determined by morphological response at the month-3 ultrasound visit. Endometrial preparation is initiated 7 days after the last dose of linzagolix.

ULTRASOUND PROTOCOL:

Standardised transvaginal ultrasound measurements at each visit: uterine volume (L x AP x T x 0.523 cm3), junctional zone maximum (mm), junctional zone minimum (mm) and junctional zone difference (mm). All measurements performed in strict sagittal plane with ≥7 MHz transvaginal probe.

VASOMOTOR SYMPTOM MANAGEMENT:

Standardised non-estrogenic supplementation protocol (Cimicifuga racemosa 20 mg, Remifemin) if EVA score ≥4 for hot flushes or insomnia. Suspended simultaneously with the last dose of linzagolix.

REGULATORY FRAMEWORK:

Observational study with medicinal products (EOMF) under Spanish Royal Decree 957/2020. Use of linzagolix in this indication is off-label. Study approved by CEIm del Hospital Clinico San Carlos, Madrid.

研究类型

观察性的

注册 (估计的)

35

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

取样方法

非概率样本

研究人群

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.

描述

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)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Linzagolix 200 mg - Adenomyosis and RIF
Patients with confirmed adenomyosis and recurrent implantation failure (2 or more failed embryo transfers with high-quality blastocysts: grade BB or above in oocyte donation cycles, or PGT-A confirmed euploid in autologous cycles) receiving linzagolix 200 mg orally once daily for 3 to 6 months prior to embryo transfer. Treatment duration is determined by morphological response assessed at the month-3 transvaginal ultrasound visit. Endometrial preparation is initiated 7 days after the last dose of linzagolix.
药品：Linzagolix 200 mg (Yselty)
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.
其他名称：
  • Yselty
  • GnRH receptor antagonist

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Live Birth Rate (LBR) per embryo transfer
大体时间：Up to 12 months after embryo transfer
Proportion of embryo transfers resulting in the birth of a live neonate at or beyond 24 weeks of gestation.
Up to 12 months after embryo transfer

次要结果测量

结果测量
措施说明
大体时间
Clinical Pregnancy Rate
大体时间：6-7 weeks after embryo transfer
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.
6-7 weeks after embryo transfer
Miscarriage Rate
大体时间：Up to 22 weeks of gestation
Proportion of clinical pregnancies ending in spontaneous pregnancy loss before 22 weeks of gestation.
Up to 22 weeks of gestation
Change in Uterine Volume
大体时间：Baseline, month 3, month 6 (if applicable) and pre-transfer (approximately 3-7 months from baseline)
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.
Baseline, month 3, month 6 (if applicable) and pre-transfer (approximately 3-7 months from baseline)
Change in Junctional Zone Maximum Thickness
大体时间：Baseline, month 3, month 6 (if applicable) and pre-transfer (approximately 3-7 months from baseline)
Change in junctional zone (JZ) maximum thickness (mm) measured by standardised transvaginal ultrasound in strict sagittal plane from baseline to post-treatment.
Baseline, month 3, month 6 (if applicable) and pre-transfer (approximately 3-7 months from baseline)
Incidence of Vasomotor Adverse Events
大体时间：Monthly during treatment period (up to 6 months)
Proportion of patients reporting hot flushes, insomnia or other vasomotor symptoms, assessed using a visual analogue scale (EVA 0-10) at each visit.
Monthly during treatment period (up to 6 months)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Vida Fertility Institute

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2028年7月1日

研究完成 (估计的)

2028年9月1日

研究注册日期

首次提交

2026年7月6日

首先提交符合 QC 标准的

2026年7月6日

首次发布 (实际的)

2026年7月13日

研究记录更新

最后更新发布 (实际的)

2026年7月13日

上次提交的符合 QC 标准的更新

2026年7月6日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • VFI-LNZG-2025

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

Individual participant data will not be shared at this stage due to the small sample size and the need to protect patient privacy in accordance with the General Data Protection Regulation (GDPR, EU 2016/679) and Spanish Organic Law 3/2018 on Personal Data Protection. Anonymised aggregate data may be made available upon reasonable request following publication of the primary results.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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