Human Chorionic Gonadotropin (hCG) Priming Prior to Controlled Ovarian Hyperstimulation (COH) in Poor Responder In Vitro Fertilization (IVF) Patients

What Was Tested

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

There is a decline in androgen concentration with ovarian aging.

Also, ovarian response to COH in IVF cycles diminishes with ovarian aging.

It had two arms (groups): hCG (active comparator) and placebo (placebo comparator).

Similar injection at same time points with similar diluent but no hCG.

The registry classes the interventions as biological.

Who Took Part

Enrollment: 60 actual participants took part.

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

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

Examples of who could join: Previous IVF cycle with 5 or less mature follicles or 5 or less oocyte retrieved.

The full record lists 1 inclusion and 2 exclusion criteria; among the exclusions: 42 years or older; BMI \<18 or \>30.

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.

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

Blinding on both sides kept the participants and researchers unaware of who received hCG (human chorionic gonadotropin).

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

It started in 2008-10 with completion listed for 2010-09.

It ran at 1 site in Spain.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: pregnancy rate (time frame: 2 weeks after intervention).

It also tracked 1 secondary outcome, for example number of oocytes retrieved.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of hCG (human chorionic gonadotropin) in 60 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.