GnRH Agonist Trigger and Modified Luteal Phase Support, Adding a Bolus of GnRHa at the Time of Implantation - a RCT

What Was Tested

In this phase 3 trial, researchers set out to test Triptorelin.

Acronyms: GnRH: gonadotropin-releasing hormone FSH: follicle stimulating hormone LH: luteinizing hormone HCG:human chorionic gonadotropin IVF:In vitro fertilization ICSI:intracytoplasmatic sperm injection OHSS:ovarian hyperstimulation syndrome OMEGA: oocyte maturation employing GnRH-agonist OPU: ovum pick up NaCl: sodium chloride.

It had two arms (groups): GnRH-agonist (experimental) and Control Arm (no intervention).

Control Arm: No intervention.

The registry classes the interventions as drug.

More on the Plan

Thus, further modifications in the luteal phase supplementation are required in order to optimise the reproductive outcome after GnRH-agonist triggering.

Who Took Part

328 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: Female age \< 40 years. Body Mass Index \> 18 and \< 35 kg/m2. No uterine (fibroids, mullerian malformations), ovarian ( endometrioma) or adnexa (hydrosalpinx) abnormalities. Patients with at least one embryo at transfer time.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: very high risk of ohss (\> 30 follicles \> 12 mm the day of ovulation triggering); fertilization failure; severe endocrinopathy.

How the Study Was Run

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

The participants were allocated by chance, so the Triptorelin group and the comparison group should start out alike.

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

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

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2014-03 with completion listed for 2017-03.

It ran at 1 site in Algeria.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: implantation rate (time frame: 5 weeks after IVF/ICSI).

It also tracked 3 secondary outcomes, for example chemical pregnancy, clinical pregnancy and live birth.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Triptorelin in 328 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.