Low Dose hCG in the Late Follicular Phase

What Was Tested

The trial (phase 4) is built around hCG (human chorionic gonadotropin).

In this study,the investigators compared two protocols for controlled ovarian hyperstimulation in infertility patients requiring IVF.

In the control group, the patient undergoes a standard antagonist protocol.

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

Patients undergo a standard antagonist protocol for in-vitro fertilisation, and are stimulated with recombinant gonadotropins.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 70 actual participants took part.

It was open to women only aged from 18 years up to 36 years.

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

Examples of who could join: \< 36 years on day of randomisation. FSH \< 12 in the early follicular phase. Normal ultrasound scan. BMI between 18 and 29 (both inclusive). Randomisation at outpatient clinic.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: endometriosis ≥ grade 3; PCO syndrome; poor responder.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

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.

Only one side, usually the participants, was kept unaware of whether hCG (human chorionic gonadotropin) was given.

Those kept unaware of assignments: investigator.

It started in 2007-09 with completion listed for 2008-01.

It ran at 1 site in Belgium.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of oocytes in both treatment groups (time frame: up to 9 months).

It also tracked 1 secondary outcome, for example Duration of stimulation in both treatment groups, amount of gonadotropins consumed in each treatment group.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of hCG (human chorionic gonadotropin) in 70 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.