A Randomised Trial Using Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) in Women Undergoing Controlled Ovarian Stimulation

What Was Tested

The trial (phase 3) is built around hCG (human chorionic gonadotropin).

It had three arms (groups): HP-hCG IM (experimental), HP-hCG SC (experimental) and rhCG (active comparator).

Highly purified human chorionic gonadotropin, intramuscularly (IM).

Highly purified human chorionic gonadotropin, subcutaneously (SC).

Recombinant human chorionic gonadotropin.

The registry classes the interventions as drug.

Who Took Part

The registry lists 176 actual participants took part.

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

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

Examples of who could join: Pre-menopausal females between the ages of 18 and 39 years. Documented history of infertility. Body mass index (BMI) between 17.5 and 32.0 kg/m2. Regular menstrual cycles.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: known endometriosis stage iii and iv; known polycystic ovarian syndrome (pcos); history of recurrent miscarriage.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Random assignment meant chance, not the researchers, decided who got hCG (human chorionic gonadotropin) and who got the comparison, which limits bias.

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

In this single-blind hCG (human chorionic gonadotropin) study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2016-04 with completion listed for 2017-07-09.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Oocytes Retrieved (time frame: Approximately 36 hours after hCG administration).

It also tracked 6 secondary outcomes, for example Number of Metaphase II (MII) Oocytes, Number of Fertilized (2 Pronuclei (2PN)) Oocytes, Positive β Unit of Human Chorionic Gonadotropin (βhCG) Rate, Clinical Pregnancy Rate, Frequency of Adverse Events (AEs) and Intensity of AEs.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of hCG (human chorionic gonadotropin) in 176 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.