MENOPUR® in a Gonadotropin-Releasing Hormone (GnRH) Antagonist Cycle With Single-Blastocyst Transfer in a High Responder Subject Population

What Was Tested

In this phase 4 trial, researchers set out to test HMG (Human Menopausal Gonadotropin).

It had two arms (groups): menotropin (experimental) and recombinant FSH (active comparator).

Menotropins for injection.

The registry classes the interventions as drug.

Who Took Part

The registry lists 620 actual participants took part.

It was open to women only aged from 21 years up to 35 years.

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

Examples of who could join: Females aged 21 to 35 years with regular ovulatory menstrual cycles of 21 to 45 days, with a Body Mass Index (BMI) between 18 and 30 kg/m2 who desire pregnancy. Subjects must be high responders, defined as subjects who have a serum anti-Müllerian hormone (AMH) ≥5 ng/mL at screening.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: known stage iii-iv endometriosis (american society for reproductive medicine, 2012); history of recurrent miscarriage not followed by a live birth (recurrent is defined as two (2) or more consecutive miscarriages).

How the Study Was Run

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

The participants were allocated by chance, so the HMG (Human Menopausal Gonadotropin) group and the comparison group should start out alike.

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

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

Those kept unaware of assignments: outcomes assessor.

It started in 2015-08-31 with completion listed for 2017-01-26.

It ran at 35 sites in United States (35).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Ongoing Pregnancy Rate (time frame: 8-9 weeks after blastocyst transfer in the fresh cycle).

It also tracked 11 secondary outcomes, for example Positive β-human Chorionic Gonadotropin (hCG) Rate, Clinical Pregnancy Rate, Early Pregnancy Loss, Follicular Development as Assessed by TVUS, Follicular Development as Assessed by TVUS and Number of Oocytes Retrieved.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of HMG (Human Menopausal Gonadotropin) in 620 people.

With 620 participants it is a large trial for this field.

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.