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Follicle Size and Oocyte Development

Plain-language guide to NCT03660813: not phased non-randomized trial of Triptorelin, 200 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03660813
Phase
not phased
Status
completed
Start
2018-07-01
Completion (planned or actual)
2021-08-01
Participants
200 (actual)
Design
non-randomized, open label (everyone knows who gets what), diagnostic
Conditions studied
IVF Treatment
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Triptorelin.

It had two arms (groups): HCG triggering (experimental) and Dual triggering (experimental).

The registry classes the interventions as diagnostic test and drug.

More on the Plan

The medications, designed to override the selection of a single dominant follicle, drive multiple antral follicles into the growth phase.

These follicles grow at different rates, and management is guided by their size rather than their competence.

Human chorionic gonadotropin (hCG) is usually used as a surrogate LH surge to induce luteinization of the granulosa cells, final oocyte maturation and resumption of meiosis.

This treatment is therefore based on an assumption that follicular size predicts the developmental competence of the oocyte.

Who Took Part

200 actual participants took part.

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

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

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: known mutation of fragile x.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

The Triptorelin group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Triptorelin study: the participants and staff both knew the treatment.

It started in 2018-07-01 with completion listed for 2021-08-01.

It ran at 1 site in Israel.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Oocyte retrieved in each of the follicular size groups (time frame: Through study completion, an average of 1 year).

It also tracked 3 secondary outcomes, for example Metaphase II oocytes (MII), Fertilization rate and Top Quality Embryo.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Triptorelin in 200 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.