GnRH Agonist Administration in the Luteal Phase of ICSI-ET Cycles

What Was Tested

This registered not phased trial tested Triptorelin.

This study was done to evaluate the reproducibility of previous findings.

It had two arms (groups): 1 (experimental) and 2 (placebo comparator).

GnRH agonist administration.

Sterile saline injection.

The registry classes the interventions as drug.

More on the Plan

Women undergoing embryo transfer following controlled ovarian hyperstimulation with a long GnRH agonist protocol were included.

Who Took Part

Enrollment: 570 actual participants took part.

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: Women undergoing embryo transfer following controlled ovarian hyperstimulation with a long GnRH agonist protocol, oocyte pick-up and ICSI. Embryo transfer performed on day 3.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: participation in another trial that was being conducted in our unit at the same time; preimplantation genetic screening cycles; day 5 embryo transfers.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

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

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

Neither the participants nor the staff measuring them knew who was on Triptorelin, so expectations could not easily colour the readings.

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

It started in 2006-09 with completion listed for 2007-07.

It ran at 1 site in Turkey (Türkiye).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Ongoing pregnancy rate beyond 20 weeks.

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

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Triptorelin in 570 people.

With 570 participants it is a large trial for this field.

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.