PPOS vs GnRH Antagonist in Ovarian Stimulation (ProGanOS Study)

What Was Tested

The trial (not phased) is built around Cetrorelix.

Participants will be randomly assigned in a 1:1 ratio to receive Progestins or GnRH antagonists.

It had two arms (groups): Progestins Primed Ovarian stimulation group (active comparator) and GnRH antagonist group (active comparator).

The registry classes the interventions as drug.

More on the Plan

Follicular monitoring will start on the fifth or sixth day of ovarian stimulation and was performed every 3-5 days thereafter using transvaginal ultrasound to record the number of developing follicles.

Measuring LH, estradiol, and progesterone serum levels will be performed on the fifth or sixth day of ovarian stimulation and oocyte maturation day (before the trigger injection).

Transvaginal ultrasound-guided oocyte retrieval will be performed 34-36 hours after trigger, with the retrieval of all follicles exceeding 10mm in diameter.

Oocyte fertilization will be carried out in vitro using ICSI.

Who Took Part

626 planned participants were the target.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: Woman aged 18-40. BMI ≤ 25kg/m2. AMH \> 1.2ng/mL or AFC \>5. Having indication for IVF treatment. Agree to have frozen embryo(s) transfer.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: undergoing ivf cycle with other protocols: down-regulation, mild stimulation, random start; oocyte donation cycles; undergoing vitrified oocyte accumulation.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Cetrorelix group and the comparison group should start out alike.

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

Being open-label, the Cetrorelix study did not mask who received what.

It started in 2024-04-24 with completion listed for 2026-06-30.

It ran at 1 site in Vietnam.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Ongoing pregnancy (time frame: At 10 weeks after embryo(s) placement).

It also tracked 31 secondary outcomes, for example The incidence of premature LH surge, The incidence of premature progesterone elevation, Number of oocytes retrieved, Number of mature oocytes, Number of day 3 embryos and Number of day 5 embryos.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cetrorelix in 626 people.

With 626 participants it is a large trial for this field.

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

More context: the Cetrorelix compound page, all human trials.