the Effects of GnRHa Add up to Routine Luteal Phase Support on Frozen Embryo Implantation in Frozen Embryo Transfer .

What Was Tested

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

The aim of the present prospective randomized controlled study was to determine the effects of GnRHa add up to routine luteal phase support on frozen embryo implantation in frozen embryo transfer (FET).

It had two arms (groups): GnRHa protocol (experimental) and routine luteal phase protocol (other).

The registry classes the interventions as drug.

More on the Plan

The exact underlying mechanism is still not clear, although it has been hypothesized that GnRH agonist either supports the corpus luteum function by inducing LH secretion by the pituitary gonadotrophin cells or stimulates the endometrium GnRH receptors .

Most of the former researches focused only on fresh embryo transfer in IVF/ICSI cycles.

Who Took Part

700 planned participants were the target.

It was open to women only aged from 20 years up to 37 years.

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

Examples of who could join: Infertile women with frozen thawed embryo transfer after HRT endometrial preparation. More than 20 years old, and less than 37 years old. BMI less than 28kg/m2. More than 1 transplantable embryo after thawing. Patients should sign the informed consent and have the willing to follow up.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: uterine malformation; diameter of intramural myoma more than 3cm; the thickness of endometrium less than 7mm on the progesterone supportive day.

How the Study Was Run

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

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.

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

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

It started in 2015-12 with completion listed for 2016-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: implantation rate (time frame: 5 weeks).

It also tracked 1 secondary outcome, for example clinical pregancy rate.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Triptorelin in 700 people.

With 700 participants it is a large trial for this field.

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

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