Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients

What Was Tested

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

It had two arms (groups): hMG-IBSA (experimental) and Menopur (active comparator).

New hMG preparation.

The registry classes the interventions as drug.

Who Took Part

The registry lists 270 actual participants took part.

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

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

Examples of who could join: Women undergoing ovarian stimulation for IVF with the following characteristics:. Able and willing to sign the Patient Consent Form and adhere to the study visitation schedule. \>18 and \<40 years old. BMI between 18 and 30 kg/m2. Less than 3 previously completed IVF cycles (i.e. completed cycle = egg recovery).

The full record lists 8 inclusion and 16 exclusion criteria; among the exclusions: age \<18 and \>40 years; one or both ovaries inaccessible for oocyte retrieval; ovarian cysts \>10 mm.

How the Study Was Run

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

Because people in this HMG (Human Menopausal Gonadotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Only one side, usually the participants, was kept unaware of whether HMG (Human Menopausal Gonadotropin) was given.

Those kept unaware of assignments: investigator.

It started in 2011-02 with completion listed for 2013-04.

It ran at 6 sites in Denmark (2), France (1), Hungary (1), Switzerland (1) and United Kingdom (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Total Number of Oocytes Retrieved (time frame: up to 24 days after treatment start).

It also tracked 12 secondary outcomes, for example Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo), Positive b-hCG Test, Controlled Ovarian Stimulation Duration (Days), 17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection;, Implantation Rate and Clinical Pregnancy Rate,.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of HMG (Human Menopausal Gonadotropin) in 270 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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