Low Dose GnRHa Early Luteal Phase Down Regulation Versus GnRHa Ultra-short Protocol for Poor Ovarian Response

Plain-language guide to NCT02940535: not phased randomized trial of hCG (human chorionic gonadotropin) and HMG (Human Menopausal Gonadotropin), 200 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02940535
Phase: not phased
Status: status unknown
Start: 2016-12
Completion (planned or actual): 2019-12
Participants: 200 (estimated)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Subfertility, Female; Ovulation Disorder
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test hCG (human chorionic gonadotropin) and HMG (Human Menopausal Gonadotropin).

The management of the poor responder patients is very difficult.

Currently, there is no any standard treatment for poor responder patients.

It had two arms (groups): one (experimental) and GnRHa Ultra-short Protocol (active comparator).

The registry classes the interventions as drug.

Who Took Part

200 planned participants were the target.

It was open to women only aged from 35 years up to 45 years.

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

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: contraindications for ivf/icsi; contraindications for pregnancy; primary ovarian insufficiency.

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.

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 2016-12 with completion listed for 2019-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: live birth (time frame: 3 years).

It also tracked 1 secondary outcome, for example clinical pregnancy rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of hCG (human chorionic gonadotropin) and HMG (Human Menopausal Gonadotropin) in 200 people.

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 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.

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.