drugset / Trial / NCT07732348
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)
Not yet recruiting
120 enrolled
Centro A.M.B.R.A. (Associazione Medici e Biologi per la Riproduzione Assistita)
RandomizedParallel-groupOpen-labelTreatment
Summary
Women undergoing IVF/ICSI who are candidates for a GnRH-antagonist protocol are randomly assigned 1:1 to oral linzagolix or the standard injectable GnRH antagonist (ganirelix or cetrorelix). A third, non-randomized group of women with a clinical indication for progestin-primed ovarian stimulation (PPOS) - for example, a need for a freeze-all strategy - is enrolled concurrently as a comparator cohort. The randomized comparison (linzagolix vs. injectable antagonist) is the primary, non-inferiority analysis; the PPOS cohort provides an exploratory, non-randomized comparison, analyzed with adjustment for baseline differences.
Timeline
- Start
- 2026-09
- Primary completion
- 2026-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cetrorelix | Other / unclassified | 0.25 mg | Subcutaneous |
| Comparator | Ganirelix | Protein / enzyme biologic | 0.25 mg | Subcutaneous |
| Comparator | Micronized progesterone | Unknown | 100 mg | Oral |
| Comparator | Micronized progesterone | Unknown | 200 mg | Oral |
| Subject | linzagolix | Unknown | 200 mg | Oral |
| Comparator | medroxyprogesterone acetate | Other / unclassified | 10 mg | Oral |