Comparison of MENOPUR Liquid and Powder in Women Undergoing Assisted Reproductive Technology (ART)

What Was Tested

The trial (phase 3) is built around HMG (Human Menopausal Gonadotropin).

Development of multiple follicles and pregnancy in ovulatory women undergoing controlled ovarian stimulation as part of an assisted reproductive technology (ART) cycle.

It had two arms (groups): MENOPUR liquid (experimental) and MENOPUR powder (active comparator).

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 405 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: Signed informed consents, prior to any trial-related procedure. Body mass index (BMI) between 17.5 and 38.0 kg/m\^2 (both inclusive) at screening. Regular menstrual cycles of 24 to 35 days, presumed to be ovulatory. At least 1 cycle with no fertility medication immediately prior to screening. Hysterosalpingography, hysteroscopy, or saline hysterosonogram documenting uterine anatomy appropriate for ART at screening or within 12 months prior to screening.

The full record lists 10 inclusion and 11 exclusion criteria; among the exclusions: more than two previous controlled ovarian stimulation cycles for in vitro fertilization (ivf)/icsi; known stage iii-iv endometriosis (american society for reproductive medicine, 2012); oocyte donor or embryo recipient; gestational or surrogate carrier.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got HMG (Human Menopausal Gonadotropin) and who got the comparison, which limits bias.

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

As a double-blind HMG (Human Menopausal Gonadotropin) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-10-25 with completion listed for 2021-05-28.

It ran at 20 sites in United States (20).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Fertilized (2 Pronuclei [2PN]) Oocytes (time frame: On Day 1 after oocyte retrieval (up to 23 days after start of stimulation)).

It also tracked 53 secondary outcomes, for example Positive Beta Human Chorionic Gonadotropin (βhCG) Rate, Clinical Pregnancy Rate, Ongoing Pregnancy Rate, Early Pregnancy Loss, Follicular Development on Stimulation Day 6 and Follicular Development on Last Day of Stimulation.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of HMG (Human Menopausal Gonadotropin) in 405 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.