GnRH Agonist and Progesterone Versus Progesterone Only for Luteal Phase Support in Antagonist Cycles

What Was Tested

The trial (phase 3) is built around Leuprolide.

The period after egg collection is called luteal phase.

In Australia, vaginal progesterone is routinely used to support the lining of the uterus so that it is susceptible to implantation of the embryos.

It had two arms (groups): controls (placebo comparator) and case (active comparator).

Normal saline of equivalent volume.

The registry classes the interventions as drug.

More on the Plan

It involves controlled ovarian stimulation, egg maturation, egg collection, fertilization and embryo culture and finally embryo culture.

The luteal phase is the latter phase of the menstrual cycle which begins with the formation of the corpora lutea and ends in either pregnancy or luteolysis.

In the IVF setting, however, luteal phase deficiency is present and over the last 40 years various regimens have been used to support luteal phase of the cycle.

There have been various other regimen used for luteal support in an attempt to further enhance luteal phase support such as oestrogen, HCG and GnRH agonist.

Who Took Part

Enrollment: 200 planned participants were the target.

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

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

Examples of who could join: Single embryo transfer. Antagonist cycle with HCG trigger. Use of progesterone as luteal phase support (crinone or progesterone pessary ). Women undergoing their first IVF cycle with TFC. Age 18-42 inclusive.

The full record lists 5 inclusion and 0 exclusion criteria.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

Blinding on both sides kept the participants and researchers unaware of who received Leuprolide.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2015-01 with completion listed for 2016-01.

It ran at 1 site in Australia.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): live birth (time frame: 1 year). on-going pregnancy (time frame: 3 months).

It also tracked 2 secondary outcomes, for example pregnancy and Ovarian hyperstimulation syndrome.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 200 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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