Administration of Follicle-stimulating Hormone (FSH) and Low Dose Human Chorionic Gonadotropin (hCG) for Oocyte Maturity While Decreasing hCG Exposure in In Vitro Fertilization (IVF) Cycles

What Was Tested

This registered phase 3 trial tested hCG (human chorionic gonadotropin).

It had two arms (groups): one (experimental) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

Recent data shows that if hCG is not administered for oocyte maturation, severe OHSS is very rare.

However, with gonadotropin releasing hormone (GnRH) agonist cycles, hCG is required.

In that study, there was no OHSS in the group that received the FSH co-trigger.

Couples undergoing IVF will be offered participation in the study.

Who Took Part

105 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.

The full record lists 0 inclusion and 11 exclusion criteria; among the exclusions: age \>41 years old; antral follicle count (afc; 2-10 mm) \< 8; body mass index \> 30 kg/m2.

How the Study Was Run

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

Because people in this hCG (human chorionic gonadotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The hCG (human chorionic gonadotropin) group and the comparison group ran side by side rather than switching.

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 and care provider.

It started in 2014-09 with completion listed for 2018-06-20.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Total Fertilization Proportion (i.e. Total Competent Proportion) (time frame: 2 days).

It also tracked 28 secondary outcomes, for example Number of Oocytes Retrieved, Number of MII Oocytes, Total Oocyte Maturity Rate, Mature Oocyte Recovery Proportion, ICSI Fertilization Rate and High Quality Cleavage-stage Embryos.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of hCG (human chorionic gonadotropin) in 105 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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