Agonist Versus Classical HCG Trigger (Poor Responders, Normoresponders and High Responders)

What Was Tested

The trial (not phased) is built around hCG (human chorionic gonadotropin) for female fertility.

Agonist triggering in controlled ovarian stimulation protocols is being used during last years (among high responder patients to avoid OHSS).

Indeed, agonist triggering is more physiologic than HCG triggering.

It had six arms (groups): Poor responders. Classical trigger (active comparator), Poor responders. Agonist trigger (experimental), Normo responders. Classical trigger (active comparator), Normo responders. Agonist trigger (experimental) and High responders. Classical trigger (active comparator).

Intervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval. Women scheduled for IVF treatment with 4 or less antral follicles in ultrasound assessment.

Intervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval. Women scheduled for IVF treatment with more than 4 and less than 16 antral follicles in ultrasound assessment.

The registry classes the interventions as drug.

More on the Plan

During the last years, ovulation triggering in controlled ovarian stimulation protocols has been used specially to avoid hyperstimulation syndromes (OHSS).

On the other hand poor responder patients to ovarian stimulation represent a challenge in assisted reproduction.

Defining poor responders is not easy, but the researchers can define them as those patients with less than 4 eggs obtained after oocyte retrieval.

Different strategies have been proposed to overcome this problem.

Who Took Part

300 planned participants were the target.

It was open to women only aged from 18 years up to 48 years.

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

Examples of who could join: Women scheduled for IVF treatment. First ovarian stimulation. Two ovaries present. No previous ovarian surgery. No contraindication for any of the assigned treatments.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: previous ovarian surgery; previous ivf treatments; absence of one ovary.

How the Study Was Run

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

The female fertility 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 female fertility participants stayed in one arm throughout.

Being open-label, the hCG (human chorionic gonadotropin) study did not mask who received what.

It started in 2017-12-18 with completion listed for 2018-02.

It ran at 1 site in Spain.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mature oocytes (time frame: Up to 24 weeks).

It also tracked 5 secondary outcomes, for example Relation mature oocytes/punctured oocytes, Fertilized oocytes, Relation fertilized oocytes/achieved Mature oocytes, Number of blastocysts developed and Cancelled cycles.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of hCG (human chorionic gonadotropin) in 300 people with female fertility.

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, Female fertility research.