Effect of a Higher Than Maximum [amount hidden] Gonadotropin Dose in an In-vitro Fertilization Cycle

What Was Tested

This registered phase 3 trial tested HMG (Human Menopausal Gonadotropin).

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 366 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: RESIDENT OF CANADA. Age 40 years or less at the time of enrollment. Primary infertility or secondary. Not previously undertaken a cycle that was included in this study.

The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: simultaneous participation in another clinical trial; body mass index (bmi) \> 38 kg/m2; early follicular phase (day 2-4) serum fsh level \> 20 miu/ml.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got HMG (Human Menopausal Gonadotropin) and who got the comparison, which limits bias.

The HMG (Human Menopausal Gonadotropin) group and the comparison group ran side by side rather than switching.

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

It started in 2009-09 with completion listed for 2013-10.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of metaphase II oocytes retrieved during the course of one treatment cycle (time frame: 2 years).

It also tracked 12 secondary outcomes, for example Number of follicles recruited per patient during stimulation, Fertilization rate per patient (number of normally fertilized (with 2 pronuclei) oocytes/number of mature oocytes collected), Embryo cleavage rate per patient (number of divided normally fertilized oocytes/number of normally fertilized oocytes), Number of embryos available per patient, Number of supernumerary embryos available for cryopreservation per patient and Implantation rate.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of HMG (Human Menopausal Gonadotropin) in 366 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.