A Study to Compare the Safety and Efficacy of Cetrotide® 3 Milligram (mg) Versus Antagon™ in Women Undergoing Ovarian Stimulation

Plain-language guide to NCT00298025: phase 4 randomized trial of hCG (human chorionic gonadotropin) and HMG (Human Menopausal Gonadotropin), 185 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00298025
Phase: phase 4
Status: completed
Start: 2003-09
Completion (planned or actual): 2004-05
Participants: 185 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Infertile Women Undergoing Assisted Reproductive Technology (ART)
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested hCG (human chorionic gonadotropin) and HMG (Human Menopausal Gonadotropin).

It had two arms (groups): Cetrotide® (experimental) and Antagon ™ (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 185 actual participants took part.

It was open to women only aged from 18 years up to 39 years.

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

Examples of who could join: Infertile women wishing to conceive whose physician had recommended that she can undergo ART. Aged 18-39 years (inclusive). Regular menstrual cycles every 25-35 days. Body mass index (BMI) less than 35 kilogram per square meter (kg/m\^2). Normal cervical cytology, documented by Pap Smear, within six months prior to OCP administration.

The full record lists 10 inclusion and 17 exclusion criteria; among the exclusions: known to be infected with human immunodeficiency virus (hiv); known to be infected with hepatitis c virus; known to test positive for hepatitis b surface antigens.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got hCG (human chorionic gonadotropin) and who got the comparison, which limits bias.

The hCG (human chorionic gonadotropin) group and the comparison group ran side by side rather than switching.

Being open-label, the hCG (human chorionic gonadotropin) study did not mask who received what.

It started in 2003-09 with completion listed for 2004-05.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of subjects without premature luteinizing hormone (LH) surge (time frame: r-hCG administration day (end of stimulation cycle {approximately 4 days})).

It also tracked 12 secondary outcomes, for example Duration of study treatment, Duration of gonadotropin therapy, Number of oocytes retrieved, Number of mature oocytes retrieved, Number of fertilized oocytes and Number and Quality of Embryos.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of hCG (human chorionic gonadotropin) and HMG (Human Menopausal Gonadotropin) in 185 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page and the HMG (Human Menopausal Gonadotropin) compound page, all human trials.

Our Notes on the Compounds

hCG (human chorionic gonadotropin): An LH analog that drives Leydig-cell testosterone production.

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

Cetrorelix: An FDA-approved GnRH antagonist used in IVF to prevent a premature LH surge.

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.