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)

What Was Tested

This registered not phased trial tested Cetrorelix for female fertility.

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.

It had three arms (groups): B - Injectable GnRH Antagonist (Ganirelix/Cetrorelix) (active comparator), C - PPOS (Progestin-Primed Ovarian Stimulation) Cohort (active comparator) and A - Linzagolix (experimental).

The registry classes the interventions as drug.

More on the Plan

Women eligible for a GnRH-antagonist protocol are randomized 1:1 to oral linzagolix or the injectable GnRH antagonist using a computer-generated permuted-block randomization sequence (block size of 4, no stratification); allocation is concealed until treatment initiation.

A separate, concurrent cohort of women with a clinical indication for PPOS is enrolled as a non-randomized comparator; because assignment to this cohort reflects clinical criteria, it may differ systematically from the randomized arms - confounding by indication limited to the PPOS comparison.

As treatment is known to investigators and patients, there is no masking (open-label); oocyte and embryo assessment follows standardized, predefined procedures.

All participants undergo a routine clinical follow-up visit 5 days after oocyte pick-up.".

Who Took Part

120 planned participants were the target.

It was open to women only aged from 18 years up to 42 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Female, aged 18 to 42 years. Population unselected for ovarian reserve (normal, poor, and high responders are eligible). Written informed consent, including consent for off-label use of linzagolix and for data processing. For the two antagonist arms (Linzagolix and Injectable GnRH Antagonist): acceptance of randomization.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: known contraindications or hypersensitivity to the study drugs; contraindications to pregnancy or to ovarian stimulation; concurrent participation in another interfering interventional study.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Cetrorelix study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Cetrorelix group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Cetrorelix study: the female fertility participants and staff both knew the treatment.

It started in 2026-09 with completion listed for 2026-12.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Mature (MII) Oocytes Retrieved (time frame: At oocyte retrieval, approximately 36 hours after trigger (first study cycle)).

It also tracked 1 secondary outcome, for example Incidence of Premature LH Rise.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cetrorelix in 120 people with female fertility.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cetrorelix compound page, Female fertility research.