Corifollitropin Alpha and Ovarian Response

What Was Tested

In this not phased trial, researchers set out to test HMG (Human Menopausal Gonadotropin).

Objective: To study whether an administration of corifollitropin alpha modifies the follicular cohort, measured by Follicular Output Rate (FORT), compared to human menopausal gonadotropin (HMG), in infertile patients undergoing in vitro fertilisation (IVF).

M/M: 306 infertile patients undergoing in vitro fertilisation (IVF).

It had two arms (groups): corifollitropin alpha (experimental) and menotropin (active comparator).

The registry classes the interventions as drug.

More on the Plan

Patients will be allocated for convenience into two groups: those who would receive corifollitropin alpha (Group 1) or HMG (Group 2).

After 3 or 5 days, one or two good-quality embryos will be transferred.

It will be performed intracytoplasmic sperm injection (ICSI) instead of conventional IVF when major male factor is presented.

Primary outcome measure is FORT.

Who Took Part

The registry lists 300 actual participants took part.

It was open to women only aged from 18 years up to 42 years.

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

Examples of who could join: Regular menstrual cycles;. Body mass index (BMI) of \<33.0 kg/m².

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: previous ovarian surgery;; current diagnosis of polycystic ovarian syndrome (pcos) or other endocrinopathies;; history of autoimmune or metabolic disorders.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the HMG (Human Menopausal Gonadotropin) study did not mask who received what.

It started in 2018-06-15 with completion listed for 2019-01-31.

It ran at 2 sites in Brazil (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): FORT (time frame: 15 days).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of HMG (Human Menopausal Gonadotropin) in 300 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the HMG (Human Menopausal Gonadotropin) compound page, all human trials.