Co-administration of Low Dose hCG at the Time of GnRH Agonist Trigger or 35 Hours Later for the Prevention of OHSS

What Was Tested

This registered phase 4 trial tested hCG (human chorionic gonadotropin).

It had two arms (groups): hCG given at time of GnRHa trigger (experimental) and hCG given 35 hours after GnRHa trigger (active comparator).

The registry classes the interventions as drug.

More on the Plan

However, the adoption of its use has not been widely accepted in view of concerns regarding potential impairment of implantation.

Intensive luteal phase supplementation with estrogen (E2) and progesterone (P) is important due to the strong evidence of abnormal luteal phase serum E2 and P profiles.

Who Took Part

89 actual participants took part.

It was open to women only aged from 18 years up to 39 years.

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

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: hypothalamic dysfunction, patients with \< 14 follicles \< 11 mm in diameter, peak serum e2 levels \>= 4,000 pg/ml.

How the Study Was Run

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

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 2013-03 with completion listed for 2015-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Ongoing Pregnancy (time frame: Through time of study completion, on average 1-2years).

It also tracked 1 secondary outcome, for example Ovarian Hyperstimulation Syndrome.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of hCG (human chorionic gonadotropin) in 89 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.