Multicenter, Randomized, Open Label, Parallel Study to Evaluate the Efficacy & Safety of IVF-M HP Inj. vs. Menopur® Inj.

Plain-language guide to NCT02458768: phase 4 randomized trial of HMG (Human Menopausal Gonadotropin), 112 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02458768
Phase: phase 4
Status: completed
Start: 2013-07
Completion (planned or actual): 2014-11
Participants: 112 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Infertility, Female
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

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

It had two arms (groups): IVF-M HP Inj. (experimental) and Menopur® Inj. (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 112 actual participants took part.

It was open to women only aged from 20 years up to 39 years.

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

Examples of who could join: Adult women from 20 through 39 years of age at the screening. Subjects with the mean menstrual cycle day (MCD) of 25 to 35 days. Subjects with the Follicle Stimulating Hormone (FSH) concentration at the screening not exceeding the upper limit of the normal range (ULN). Those diagnosed with infertility due to at least one of the following causes of infertility. Fallopian tubal factor.

The full record lists 12 inclusion and 21 exclusion criteria; among the exclusions: subjects contraindicated to pregnancy; subjects with bmi \> 30 (bmi; kg/m2); subjects diagnosed with polycystic ovary syndrome (pcos).

How the Study Was Run

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

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 participants stayed in one arm throughout.

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

It started in 2013-07 with completion listed for 2014-11.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Retrieved Oocytes (time frame: 36 hrs (±3 hrs) after administration of the ovulation stimulant).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of HMG (Human Menopausal Gonadotropin) in 112 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.

Our Notes on the Compound

HMG (Human Menopausal Gonadotropin): Menotropins: a glycoprotein preparation that supplies follicle-stimulating hormone (FSH) and luteinizing hormone (LH) activity.

HMG (Human Menopausal Gonadotropin) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.