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Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist for Ovarian Stimulation in IVF/ICSI
Sponsor: Centro A.M.B.R.A. (Associazione Medici e Biologi per la Riproduzione Assistita)
Summary
This study compares two medications used to prevent a premature hormone surge (LH surge) during controlled ovarian stimulation for in vitro fertilization (IVF). The standard approach uses an injectable GnRH antagonist (ganirelix or cetrorelix), given as a daily injection under the skin. This study evaluates linzagolix, an oral GnRH antagonist already approved for uterine fibroids and endometriosis, used here for the first time in ovarian stimulation (off-label use). Women undergoing IVF/ICSI at CENTRO AMBRA will be randomly assigned (1:1) to receive either oral linzagolix (200 mg/day) or the standard injectable antagonist. The study's hypothesis is that linzagolix is not inferior to the injectable antagonist in the number of mature (MII) eggs retrieved, within a pre-specified margin of 2.0 oocytes, while offering the advantage of oral rather than injectable administration. A separate, non-randomized group of women who are clinically indicated for a progestin-based stimulation protocol (PPOS) with a freeze-all strategy will be enrolled at the same time for descriptive comparison. Secondary objectives include how effectively each treatment suppresses the LH surge, whether a GnRH agonist can be used to safely trigger final egg maturation under linzagolix, the occurrence of ovarian hyperstimulation syndrome (OHSS) and other safety outcomes, the length of stimulation and amount of hormone medication needed, and embryology outcomes such as fertilization and blastocyst formation rates. The study plans to enroll approximately 189 women in total.
Official title: Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist in Controlled Ovarian Stimulation for In Vitro Fertilization: A Randomized Controlled Non-Inferiority Trial With a Concurrent Comparator Cohort Undergoing Progestin-Primed Ovarian Stimulation (PPOS)
Key Details
Gender
FEMALE
Age Range
18 Years - 42 Years
Study Type
INTERVENTIONAL
Enrollment
189
Start Date
2026-09
Completion Date
2026-12
Last Updated
2026-07-28
Healthy Volunteers
No
Conditions
Interventions
Linzagolix
Linzagolix Type: Drug Arm: A Description: Linzagolix 200 mg administered orally once daily, started per center protocol (fixed stimulation day or upon appearance of the dominant follicle) and continued through the day of trigger. Investigational off-label use for suppression of the premature LH surge during controlled ovarian stimulation.
Ganirelix ; Cetrorelix
Ganirelix Type: Drug Arm: B Description: Ganirelix acetate 0.25 mg administered by daily subcutaneous injection, per fixed or flexible protocol according to center practice, to suppress the premature LH surge during controlled ovarian stimulation. Cetrorelix Type: Drug Arm: B Description: Cetrorelix acetate 0.25 mg administered by daily subcutaneous injection, per fixed or flexible protocol according to center practice, to suppress the premature LH surge during controlled ovarian stimulation.
Medroxyprogesterone Acetate ; Dienogest ; Micronized Progesterone
Medroxyprogesterone Acetate Type: Drug Arm: C Description: Medroxyprogesterone acetate 10 mg/day administered orally from stimulation day 1-2 through the day of trigger, as part of a progestin-primed ovarian stimulation (PPOS) protocol with mandatory freeze-all strategy. Dienogest Type: Drug Arm: C Description: Dienogest 2 mg/day administered orally from stimulation day 1-2 through the day of trigger, as part of a progestin-primed ovarian stimulation (PPOS) protocol with mandatory freeze-all strategy. Micronized Progesterone Type: Drug Arm: C Description: Micronized progesterone 100-200 mg/day administered orally from stimulation day 1-2 through the day of trigger, as part of a progestin-primed ovarian stimulation (PPOS) protocol with mandatory freeze-all strategy.