Co Administration of GnRH Agonist and hCG for Final Oocyte Maturation

What Was Tested

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

The investigators therefore aim to perform a prospective randomized controlled study in normal responders, comparing cycles triggered with hCG to those triggered with hCG+GnRH agonist.

It had two arms (groups): Double trigger (experimental) and control (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

A prospective, randomized, double blinded clinical trial.

Patients will undergo standard clinical and hormonal investigation as usual for IVF.

All patients will be supplemented with the usual progesterone preparation (vaginal progesterone suppositories) for luteal support.

Who Took Part

276 actual participants took part.

It was open to women only aged from 18 years up to 41 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Women during one of their first 3 IVF cycle attempts. Women between the ages of 18-42. BMI (body mass index) of 18-35. AMH (Anti mullerian hormone) \> 1 ng/ml.

The full record lists 6 inclusion and 19 exclusion criteria; among the exclusions: women with low ovarian response; previous enrollment in this study; hypersensitive to suprefact/pregny/gonal f/purigon/menopur/progesterone, and/or their ingredients/components of the formulation.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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.

Neither the participants nor the staff measuring them knew who was on hCG (human chorionic gonadotropin), so expectations could not easily colour the readings.

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

It started in 2016-03 with completion listed for 2018-09.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of mature oocytes (time frame: 2 days after randomization).

It also tracked 1 secondary outcome, for example Blastocyst rate.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of hCG (human chorionic gonadotropin) in 276 people.

The trial is marked completed; 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.