KISS-IVF-TRIGGER — design and population

§2Design and population

§2.1Design and allocation

Design class

Single-arm open-label study

Masking

None

Arms

1

Allocation

Single arm; no randomisation

Endpoint adjudication

Not applicable to the primary endpoint of this design

Data monitoring

As specified in the protocol

§2.2Arms

Table 2. Randomised arms. Illustrative: arm-level allocations are reconstructed by the Institute from the design class and the randomised total where the published report does not state them.

§2.3Population

Indication. Growth hormone deficiency and growth-hormone secretagogue pharmacology

Insufficient endogenous growth-hormone secretion, or the pharmacological stimulation of the growth-hormone axis, assessed here principally through provocative testing and IGF-1 response.

Geographic footprint. United Kingdom · Czechia · Republic of Korea · China.

§2.4Eligibility as the Institute reads it

• Included. Insufficient endogenous growth-hormone secretion, or the pharmacological stimulation of the growth-hormone axis, assessed here principally through provocative testing and IGF-1 response.
• Excluded. Participants for whom the intervention is contraindicated, including not established — no marketing authorisation. Exclusion criteria narrow the population to which the estimate applies and are the principal source of indirectness where a trial estimate is applied to ordinary practice.