Study to Examine Effect of Recombinant Luteinizing Hormone (r-Lh) and Recombinant Human Chorionic Gonadotropin (r-hCG) for Ovarian Stimulation in Assisted Reproduction Techniques (ART)

Plain-language guide to NCT01339299: phase 4 randomized trial of hCG (human chorionic gonadotropin), 100 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01339299
Phase: phase 4
Status: completed
Start: 2009-10
Completion (planned or actual): 2012-07
Participants: 100 (actual)
Design: randomized, open label (everyone knows who gets what), basic_science
Conditions studied: Controlled Ovarian Stimulation; Infertility
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

In this phase 4 trial, researchers set out to test hCG (human chorionic gonadotropin).

It had two arms (groups): recombinant luteinizing hormone (experimental) and recombinant human chorionic gonadotrofin (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 100 actual participants took part.

It was open to women only aged from 18 years up to 35 years.

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

Examples of who could join: Women who plan to undergo IVF or ICSI treatment. Woman's age \> 18 years but ≤ 35 years. Regular menstrual cycle (25-34 days). BMI 18 to 30 inclusive. Signed patient information and informed consent forms.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: more than 2 prior ivf/icsi attempts; diabetes mellitus, epilepsy, lever-, kidney-, heart- and metabolism disorders, according to the investigator's assessment.

How the Study Was Run

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

The participants were allocated by chance, so the hCG (human chorionic gonadotropin) group and the comparison group should start out alike.

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 2009-10 with completion listed for 2012-07.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): The Oestradiol Concentration on the Day of Ovulation Induction (time frame: treatment day 10 to 14).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of hCG (human chorionic gonadotropin) in 100 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.

Our Notes on the Compound

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

hCG (human chorionic 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.