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Agonist Trigger With HCG Luteal Supplementation vs HCG Trigger With Progesterone Luteal Supplementation in Antagonist Controlled HyperstimulationCycle

Plain-language guide to NCT04846218: not phased randomized trial of Triptorelin, 100 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04846218
Phase
not phased
Status
completed
Start
2016-12
Completion (planned or actual)
2020-01
Participants
100 (actual)
Design
randomized, triple-blind, treatment
Conditions studied
Infertility, Female
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Triptorelin.

The aim of the current study is to compare agonist trigger and HCG luteal support vs standard HCG trigger and progesterone luteal supplementation in antagonist controlled hyperstimulation cycle as regards to clinical pregnancy rate.

It had two arms (groups): Group 1 (active comparator) and Group 2 (active comparator).

The registry classes the interventions as drug.

More on the Plan

Prospective Interventional randomized pilotstudy on patients undergoing controlled ovarian hyperstimulation.

After 6 days of stimulation, FSH will be adjusted according to ovarian response.

Who Took Part

Enrollment: 100 actual participants took part.

It was open to women only aged from 20 years up to 39 years.

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

Examples of who could join: Age between 20 and 39 years. Body mass index between 18 and 30. Unexplained infertility or male factor infertility.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: endocrinological disorder eg.:hyperprolactenemia, hypo or hyper thyrodism; more than 2 previous attemptsof ivf; any uterine anatomical anomaly.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Triptorelin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Triptorelin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2016-12 with completion listed for 2020-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Clinical pregnancy rate (time frame: 1 year).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Triptorelin in 100 people.

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

More context: the Triptorelin compound page, all human trials.

Our Notes on the Compound

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.