GnRH Agonist at Embryo Transfer: IVF Outcomes

What Was Tested

The trial (phase 3) is built around Leuprolide.

In ART (assisted reproductive technology) cycles, embryos are transferred to a woman's uterus after in-vitro fertilization (IVF) in a laboratory.

Usually, hormones (progesterone) are given to the patient after transferring the embryo, as a supplement, in order to mimic the natural hormones that would normally be secreted in an unassisted pregnancy.

It had two arms (groups): Saline Solution for Injection (placebo comparator) and Leuprolide Acetate (experimental).

The registry classes the interventions as drug.

More on the Plan

This is a randomized, double-blinded, placebo-controlled study.

Patients undergoing day 3 embryo transfers will not be eligible and will not be randomized.

Randomization will be in 22 blocks of 20 patients.

Based on the power analysis with a power of 0.8 and alpha-error of 0.05, the investigators will need to enroll 352 patients, so the investigators will recruit 440 to account for attrition.

Who Took Part

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: Women undergoing in-vitro fertilization who are receiving an embryo transfer of a day 5 blastocyst.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: those who have a contraindication to receiving the medication.

How the Study Was Run

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

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

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

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

Those kept unaware of assignments: participant and care provider.

It started in 2019-04-15 with completion listed for 2020-06-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Live birth rate (time frame: 2 years).

It also tracked 2 secondary outcomes, for example Miscarriage rate and Clinical pregnancy rate.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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