Cetrotide Treatment Optimization

What Was Tested

This registered phase 4 trial tested Cetrorelix.

However, the optimal GnRH antagonist protocol is still not known.

It had two arms (groups): CD2 (experimental) and CD6 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 617 actual participants took part.

It was open to women only aged from 18 years up to 39 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Normo-ovulatory women \< 39 years with an indication for IVF or ICSI.

The full record lists 1 inclusion and 2 exclusion criteria; among the exclusions: more than 2 previous unsuccessful ivf/icsi cycles; BMI \> 32 kg/m2.

How the Study Was Run

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

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.

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

It started in 2009-02 with completion listed for 2012-10.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Live Birth Rate Per Started Cycle and Live Birth From Cryopreserved Embryos Originating From, and Occurring Within 6 Months of the Initial Treatment Cycle Will be Included in the Total Live Birth Rate Per Started Cycle (time frame: 2 years).

It also tracked 1 secondary outcome, for example Cumulative Ongoing Pregnancy Rate.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cetrorelix in 617 people.

With 617 participants it is a large trial for this field.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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