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Dual Trigger to Reduce Ovarian Hyperstimulation Syndrome

Plain-language guide to NCT02022228: not phased randomized trial of hCG (human chorionic gonadotropin) and Triptorelin, 200 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT02022228
Phase
not phased
Status
status unknown
Start
2012-07
Completion (planned or actual)
2015-12
Participants
200 (estimated)
Design
randomized, open label (everyone knows who gets what), prevention
Conditions studied
Infertility and at High Risk of OHSS
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 Triptorelin.

However, lower oocyte yield was reported in patients with lower luteinizing hormone (LH) level post trigger with single injection of GnRH agonist, which might be related to the shorter duration and lower amount of LH induced by GnRH agonist.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

200 planned participants were the target.

It was open to women only aged up to 40 years.

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

Examples of who could join: Patients with polycystic ovarian syndrome. Patients with polycystic ovarian morphology on ultrasound. Patients who previously experienced an ovarian stimulation cycle, with a high response to gonadotrophins.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: patients undergoing coasting; patients with past ovarian surgery.

How the Study Was Run

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

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 2012-07 with completion listed for 2015-12.

It ran at 1 site in China.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: clinical pregnancy rate per transfer cycle (time frame: 1month post embryo transfer). numbers of patients having OHSS (time frame: 2 weeks post trigger with dual GnRHa). oocyte yield (time frame: oocyte retrieval day (34 to 38 hours post trigger with GnRHa and hCG)).

It also tracked 4 secondary outcomes, for example serum luteinizing hormone level 12 hours post trigger, serum hCG level 12 hours post trigger, fertilization rate and implantation rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of hCG (human chorionic gonadotropin) and Triptorelin 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 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.

Related Pages

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.