Dual Trigger" in IVF Patients at High Risk of Ovarian Hyper Stimulation Syndrome

What Was Tested

In this phase 4 trial, researchers set out to test hCG (human chorionic gonadotropin).

By examining freeze-all cycles with frozen embryo transfer(s) (FET) only, the researchers eliminate the potential confounding issue of inadequate luteal support to the endometrium and focus primarily on the effect of a "dual trigger" on oocyte quality and embryo potential.

To their best knowledge, there have been no randomized, controlled trials conducted to address this hypothesis.

It had two arms (groups): Treatment Arm- Group A (experimental) and Control Arm- Group B (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

These findings may be partly explained by an inadequate LH surge, following a GnRH-a trigger, and raises two separate concerns.

The first concern is whether an inadequate LH surge can have an detrimental effect on luteal support following a fresh embryo transfer.

The corpus luteum requires constant LH stimulation, during implantation and early gestation, in order to optimize endometrial receptivity via the production of progesterone.

Who Took Part

Enrollment: 80 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: They are between the ages of 18 and 40. They are undergoing IVF treatment with a GnRH antagonist protocol. During their current treatment cycle, they have at least one of the following risk factors for OHSS:. Greater or equal to 13 follicles measuring at least 11 mm on the day of trigger.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: they are using a gnrh agonist protocol (which is a contraindication to using a gnrh agonist trigger); they are planning on using a "dual trigger" (based on poor outcomes in a previous ivf cycle using a gnrh agonist trigger); they have had a previous failed gnrh agonist trigger.

How the Study Was Run

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

The participants were allocated by chance, so the hCG (human chorionic gonadotropin) group and the comparison group should start out alike.

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

As a double-blind hCG (human chorionic gonadotropin) study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2019-05-01 with completion listed for 2023-12-31.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Total number of Day 5 embryos (time frame: after 5 days of oocyte fertilization).

It also tracked 11 secondary outcomes, for example Total number of oocytes retrieved per cycle, Total number of mature oocytes (MII) retrieve per IVF/ICSI cycle, Total number of fertilized zygotes, Fertilization rate, Total number of Day 3 embryos and Pregnancy Rate.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of hCG (human chorionic gonadotropin) in 80 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.