Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07732348 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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)

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 38% 195 → 120 participants
See other at-risk trials from Centro A.M.B.R.A. (Associazione Medici e Biologi per la Riproduzione Assistita)

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment reduced: 195 → 120 participants Show 5 more changesShow less
    • Phase changed: not specified → not applicable
    • Interventions modified
    • Eligibility criteria expanded, about 9 words
    • Study description shortened, about 432 words
    • Study title expanded, about 5 words
  2. Phase changed: Early Phase 1 → not specified
    • Enrollment target: 189 to 195
    • Study description shortened, about 354 words
    • Study title expanded, about 13 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07732348
Lead Sponsor Centro A.M.B.R.A. (Associazione Medici e Biologi per la Riproduzione Assistita)
Conditions
(from sponsor)		 Infertility, Female, Ovulation Induction
Related terms Infertility, Female
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov