GnRH Agonist as Luteal Support in FET Cycles

What Was Tested

In this phase 4 trial, researchers set out to test Triptorelin.

Aim: To compare the results of frozen thawed embryo transfers with and without GnRHa analogue support Primary end point: IR, PR, on going PR Secondary end point: hCH, E2 and progesterone levels 14 days after thawing.

It had four arms (groups): Natural cycle, control (no intervention), Natural cycle, intervention (experimental), Hormone replacement cycle, control (no intervention) and Hormone replacement cycle, intervention (experimental).

Treatment cycles with normal luteal support with progesteron.

Standard hormone replacement cycle with estrogen and progesteron.

The registry classes the interventions as drug.

Who Took Part

The registry lists 100 actual participants took part.

It was open to women only aged from 20 years up to 45 years.

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

Examples of who could join: 20 - 45 year old women comig to frozen thawed embryo transfer.

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: the age of the woman over 42 years during the initial icf/icsi- treatment from which the embryos derive; abnormal uterus; known abnormality of karyotype of the woman or her partner.

How the Study Was Run

The set-up was randomized, crossover and open-label.

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

In the crossover set-up each of the participants took both Triptorelin and the comparison in turn, acting as their own control.

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

It started in 2013-05 with completion listed for 2015-04.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Pregnancy rate (time frame: five weeks after the embryo transfer). Implantation rate (time frame: five weeks after the embryo transfer). Ongoing pregnancy rate (time frame: ten weeks after the embryo transfer).

It also tracked 1 secondary outcome, for example hCG- level.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Triptorelin in 100 people.

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

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