← Human Trials & Peer-Reviewed Studies

Comparison of Triggers in Double Ovarian Stimulation (DuoStim).

Plain-language guide to NCT05321511: phase 4 randomized trial of Triptorelin, 165 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05321511
Phase
phase 4
Status
status unknown
Start
2022-03-03
Completion (planned or actual)
2022-12-31
Participants
165 (estimated)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
IVF; LOW OVARIAN RESPONSE
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Triptorelin.

The main objective is to compare the number of all retrieved oocytes and mature oocytes in patients predicted to be low ovarian responders.

This is a controlled randomized clinical study where 165 patients will be recruited.

It had three arms (groups): a-GnRH (active comparator), hCG (active comparator) and a-GnRH + hCG (experimental).

The registry classes the interventions as drug.

Who Took Part

165 planned participants were the target.

It was open to women only aged from 28 years up to 43 years.

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

Examples of who could join: BMI below 32. Presence of both ovaries. Indication for ovarian stimulation under Double Stimulation protocol (Duo Stim). Meeting the criteria for Duo Stim. Medical history, history and physical examination without alterations.

The full record lists 9 inclusion and 2 exclusion criteria; among the exclusions: non-compliance with instructions and/or non-formalization of consents or legal requirements for ivf; concurrent participation in another study.

How the Study Was Run

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

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.

Being open-label, the Triptorelin study did not mask who received what.

It started in 2022-03-03 with completion listed for 2022-12-31.

It ran at 4 sites in Spain (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): number of retrieved oocytes (time frame: through study completion, usually will be evaluated on the last day of the treatment). number of mature (MII) oocytes (time frame: through study completion, usually will be evaluated on the last day of the treatment).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Triptorelin in 165 people.

Its status is unknown; 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.