Linzagolix in Adenomyosis and Recurrent Implantation Failure
NCT07698561
· ctgov
not_yet_recruiting
- Enrollment
- 30
- Start
- 2027-01-01
- Completion
- 2028-09-01
- Last updated
- 2026-10-21
- Has results
- False
- Countries
- Spain
Conditions
Tagged with
Interventions
-
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) and serum estradiol levels (\>40 pg/ml) at the month-3 visit.O ff-label use for adenomyosis prior to embryo transfer.
Eligibility criteria
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)
License: public-domain-us
· commercial use OK
· attribution required
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine