Menopur Mixed Protocol

What Was Tested

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

The objective of this study was to compare the fertilization rate between the combination of Menopur and Bravelle mixed in the same syringe and Menopur alone, both administered subcutaneously (SC), in subjects undergoing Assisted Reproductive Technology (ART).

Additionally the study assessed subjects' ability to mix and store the combination of Menopur and Bravelle and to assess safety of the Menopur and Bravelle combination.

It had two arms (groups): Menopur and Bravelle combination (experimental) and Menopur alone (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 122 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: Infertile pre-menopausal female subjects. Anti-mullerian hormone (AMH) \> 1 ng/mL and \< 3 ng/mL at screening. Eligible for in-vitro fertilisation (IVF) or ICSI treatment.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: oocyte donor or embryo recipient; gestational or surrogate carrier; inadequate number of oocytes, defined as fewer than 5 oocytes retrieved in previous art attempts; undergoing blastomere biopsy and other experimental art procedures.

How the Study Was Run

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

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.

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

It started in 2011-07 with completion listed for 2012-01.

It ran at 10 sites in United States (10).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Fertilization Rate.

It also tracked 5 secondary outcomes, for example Summary of the Subject Comprehension Questionnaire (SCQ) on Day 1, Summary of the Subject Comprehension Questionnaire (SCQ) on Day 6, Summary of Assessor Questionnaire on Day 1, Summary of Assessor Questionnaire on Day 6 and Participants With Treatment Emergent Adverse Events (TEAEs), Including Ovarian Hyperstimulation Syndrome (OHSS).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of HMG (Human Menopausal Gonadotropin) in 122 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.