MENOPUR® Versus FOLLISTIM®

What Was Tested

This registered phase 4 trial tested HMG (Human Menopausal Gonadotropin).

It had four arms (groups): Menopur/Endometrin (experimental), Menopur/Progesterone in Oil (experimental), Follistim/Endometrin (active comparator) and Follistim/Progesterone in Oil (active comparator).

The registry classes the interventions as drug.

More on the Plan

This multicenter, randomized, open-label exploratory study will be performed in approximately 200 healthy females undergoing in vitro fertilization (IVF).

Each study center will follow its study center standard practice for in vitro fertilization (IVF) within the study parameters as noted in this protocol.

Subjects will be randomly assigned prior to the start of stimulation to highly purified menotropin (Menopur®) or follitropin beta (Follistim Pen®) for stimulation and progesterone vaginal insert (Endometrin®) or progesterone in oil for luteal support.

All subjects will be required to complete a final study visit at completion of luteal support or negative serum pregnancy test following embryo transfer.

Who Took Part

The registry lists 173 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: Pre-menopausal females between the ages of 18 and 42 years. Body mass index (BMI) of 18-34. Transvaginal ultrasound at screening consistent with findings adequate for assisted reproductive technology (ART) with respect to uterus and adnexa. Signed informed consent.

The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: gestational or surrogate carrier, donor oocyte; presence of any clinically relevant systemic disease (e.g., insulin-dependent diabetes mellitus, uterine cancer); history of recurrent pregnancy loss (\>2).

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.

Nothing was hidden in this open-label HMG (Human Menopausal Gonadotropin) study: the participants and staff both knew the treatment.

It started in 2008-12 with completion listed for 2009-11.

It ran at 7 sites in United States (7).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Participants With Ongoing Pregnancy at Week 8 (time frame: Week 8 (Week 6 of gestation)).

It also tracked 10 secondary outcomes, for example Number of Follicles Observed at Day 15, Number of Oocytes Retrieved at Day 18, Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved, Number of Embryos Transferred at Three Stages of Development, Number of Embryos Frozen at Day 24 and Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of HMG (Human Menopausal Gonadotropin) in 173 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.