Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)

What Was Tested

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

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

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

It had four arms (groups): Menotropin/Progesterone vaginal insert (experimental), Menotropin/Progesterone in oil (experimental), Follitropin beta/Progesterone vaginal insert (active comparator) and Follitropin beta/Progesterone in oil (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 110 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. Diagnosed with polycystic ovary syndrome (PCOS), using criteria adopted as the 2003 Rotterdam PCOS Consensus (2 out of 3, excluding other etiologies \[congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome\]). Oligo- or anovulation. Clinical and/or biochemical signs of hyperandrogenism. Body mass index (BMI) of 18-39.

The full record lists 10 inclusion and 11 exclusion criteria; among the exclusions: gestational or surrogate carrier, donor oocyte; history of recurrent pregnancy loss, defined as more than two clinical losses; presence of abnormal uterine bleeding of undetermined origin.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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 pcos participants stayed in one arm throughout.

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

It started in 2009-01 with completion listed for 2010-07.

It ran at 6 sites in United States (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3 (time frame: weeks 1-3).

It also tracked 13 secondary outcomes, for example Number of Follicles Observed at Day 15, Number of Oocytes Retrieved at Day 18, Percentage of Oocytes Fertilized of the Total Number of Oocytes Retrieved, Number of Embryos Transferred at Three Stages of Development Before Implantation, Number of Embryos Frozen and Percentage of Participants With Biochemical Pregnancy at Approximately Day 38.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of HMG (Human Menopausal Gonadotropin) and Leuprolide in 110 people with pcos.

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 and the Leuprolide compound page, PCOS research.