GnRH Agonist for Dual Trigger in IVF and for Luteal Phase Support in FET

What Was Tested

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

It had four arms (groups): IVF: dual trigger (active comparator), IVF: hCG trigger (placebo comparator), FET: agonist (active comparator) and FET: control (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Trial design: A randomised, double-blinded and placebo controlled trial will be performed in IVF cycles and another randomised, double-blinded and placebo controlled trial will be performed in FET cycles.

Treatment of subjects: IVF Women being scheduled for IVF at Department of Obstetrics \& Gynaecology of Kwong Wah Hospital and Queen Mary Hospital will be assessed for eligibility.

Eligible women will be recruited for the study and each woman will only be included in the study.

Informed written consent will be obtained after counseling.

Who Took Part

The registry lists 784 planned participants were the target.

It was open to women only aged from 18 years up to 42 years.

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

The full record lists 0 inclusion and 11 exclusion criteria; among the exclusions: preimplantation genetic diagnosis treatment; use of donor oocytes or donor embryos; women at risk of ohss.

How the Study Was Run

The set-up was 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.

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

As a double-blind Triptorelin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2019-09-01 with completion listed for 2024-09-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Live birth rate (time frame: after 22 weeks).

It also tracked 7 secondary outcomes, for example Pregnancy, Clinical pregnancy, Biochemical pregnancy, Ongoing pregnancy, Implantation rate and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Triptorelin in 784 people.

With 784 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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