Combination of Gonadotropin-releasing Hormone Agonist and Human Chorionic Gonadotropin Triggered by Normal Responder in GnRH-antagonist Cycles

Plain-language guide to NCT02862782: phase 3 randomized trial of hCG (human chorionic gonadotropin) and Triptorelin, 1000 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02862782
Phase: phase 3
Status: status unknown
Start: 2016-09
Completion (planned or actual): 2019-09
Participants: 1000 (estimated)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: In-vitro Fertilization
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 3 trial, researchers set out to test hCG (human chorionic gonadotropin) and Triptorelin.

Background The trigger for the final maturation of the ovum by providing integration of Human Chorionic Gonadotropin (hCG) and Gonadotropin - releasing hormone (GnRH) agonist was first introduced long ago, but clinically not accepted until the advent of GnRH antagonist protocol in IVF treatment.

It had two arms (groups): hCG (experimental) and hCG + GnRH agonist (experimental).

The registry classes the interventions as drug.

More on the Plan

PATIENTS \& METHODS Women treated through IVF by protocol Gnarl - Antagonist.

Who Took Part

The registry lists 1000 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Women who are going through IVF by protocol GnRH - Antagonist.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: women with ovarian hyperstimulation syndrome.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this hCG (human chorionic 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.

Everyone knew when hCG (human chorionic gonadotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2016-09 with completion listed for 2019-09.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Clinical pregnancies rate (time frame: 1 month).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of hCG (human chorionic gonadotropin) and Triptorelin in 1000 people.

With 1000 participants it is a large trial for this field.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compounds

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

Triptorelin: A 10-amino-acid GnRH analog (Trelstar, Decapeptyl, Triptodur) used in prostate cancer, early puberty and fertility protocols.

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.