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Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist and Progestin-primed Ovarian Stimulation (PPOS) in Controlled Ovarian Stimulation for in Vitro Fertilization: a Prospective Comparative Observational Study
Sponsor: Centro A.M.B.R.A. (Associazione Medici e Biologi per la Riproduzione Assistita)
Summary
Preventing a premature rise in luteinizing hormone (LH) is essential during ovarian stimulation for in vitro fertilization (IVF), because such a rise can reduce the number of eggs collected. Current practice relies on either a daily injectable GnRH antagonist or an oral progestin (PPOS), which requires that all embryos be frozen. Linzagolix is an oral GnRH antagonist already approved for uterine fibroids and endometriosis. It has not previously been used to control ovarian stimulation for IVF; this study represents its first use for this purpose. This is an observational study: participants are not randomly assigned to a treatment. Each woman receives one of three approaches - oral linzagolix, an injectable GnRH antagonist (ganirelix or cetrorelix), or PPOS - chosen by the clinical team based on her individual situation. The three groups are then compared using statistical adjustment for baseline differences between them. The study will enroll approximately 195 women undergoing IVF or ICSI, aged 18 to \[42\], who are not selected based on ovarian reserve. All participants receive individualized gonadotropin stimulation and standard monitoring; only the method used to prevent premature ovulation differs by group. The main question is whether linzagolix leads to a similar number of mature eggs (MII) retrieved compared with the injectable antagonist. The study will also assess how well each approach suppresses LH, safety (including ovarian hyperstimulation), and the number of injections needed.
Key Details
Gender
FEMALE
Age Range
18 Years - 42 Years
Study Type
OBSERVATIONAL
Enrollment
195
Start Date
2026-09
Completion Date
2026-12
Last Updated
2026-08-03
Healthy Volunteers
No
Conditions
Interventions
Ganirelix ; Cetrorelix
Ganirelix Type: Drug Group: 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 Group: 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.
Linzagolix
Description: Linzagolix Type: Drug Group: 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.