Gonadotropin-releasing Hormone Antagonist on Triggering Day: A Randomized Controlled Study

What Was Tested

The trial (not phased) is built around Cetrorelix.

However, there is still no consensus on the optimal GnRH antagonist protocol.

It had two arms (groups): A (active comparator) and B (experimental).

Stimulated as conventional protocol.

GnRH antagonist stopped one day earlier than conventional protocol.

The registry classes the interventions as drug.

Who Took Part

80 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Both ovaries present with no morphological abnormalities. Normal ovulatory cycle with cycle lengths of between 25 and 35 days. Basal serum FSH (day 3) level of \< 15 mIU/mL. Body mass index (BMI) ranging between 18 and 27 kg/m2.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: history of a poor ovarian response; evidence of endocrine abnormalities, such as, hyperprolactinemia, thyroid dysfunction, or polycystic ovary syndrome; severe endometriosis (stage iii-iv).

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

In this single-blind Cetrorelix study one party knew the assignments and the other did not.

Those kept unaware of assignments: care provider.

It started in 2007-11 with completion listed for 2009-08.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Maturity of oocytes, fertilization rate, embryo quality (time frame: 3 days).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cetrorelix in 80 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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