The Use of GnRH Agonist Trigger for Final Follicle Maturation in Women Undergoing Assisted Reproductive Technologies

What Was Tested

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

This is a prospective comparative randomized controlled trial investigating the effect of two GnRH agonist trigger protocols on the ongoing pregnancy rate in hyper-responder women undergoing assisted reproductive technology.

It had two arms (groups): one (experimental) and one (no intervention).

The registry classes the interventions as drug.

More on the Plan

Follicle maturation triggering is the final differentiation process of an immature egg before fertilization, either in normal or stimulated ovarian cycles in assisted reproductive techniques.

This step has traditionally been accomplished by the administration of human chorionic gonadotropin (hCG) trigger which mimics LH activity.

A profoundly deficient luteal phase is believed to be the cause of compromised reproductive outcome.

In this study, the researchers aim to validate the above clinical impression and assess associated parameters of success.

Who Took Part

The registry lists 277 actual participants took part.

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

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

Examples of who could join: Normal uterine cavity (as assessed by hysteroscopy or HSG). Normal hormonal investigation: TSH, PRL. More than 15 follicles (≥12 mm in diameter) on ultrasound, and/or estradiol level of \> 3500 pg/ml on the day of trigger.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: history of three or more miscarriages; history of three or more previous ivf failures; abnormal uterine cavity (hysteroscopy or hsg).

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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 2017-03-01 with completion listed for 2021-07-01.

It ran at 1 site in Lebanon.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Ongoing pregnancy rate in hyper-responder women undergoing assisted reproductive technology cycles (time frame: 20 weeks from Last Menstrual Period (LMP)).

It also tracked 1 secondary outcome, for example Oocyte collection rate.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Triptorelin in 277 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.