Resumen

El objetivo de este ensayo clínico es determinar si la prueba de triptorelina es útil para el diagnóstico precoz del hipogonadismo hipogonadotrófico en adolescentes. Las preguntas principales que pretende responder son: • ¿Las respuestas de gonadotropinas y esteroides gonadales a la prueba de triptorelina son útiles para diagnosticar precozmente el hipogonadismo hipogonadotrófico? Los investigadores compararán las gonadotropinas y los esteroides gonadales en respuesta a la prueba subcutánea de triptorelina con la infusión clásica de GnRH para diagnosticar el hipogonadismo hipogonadotrófico. Los participantes realizarán dos pruebas: * Prueba de triptorelina (subcutánea) * Prueba de infusión de LHRH

Elegibilidad

Edad mínima: 13 YearsSexo: ALL

Criterios de inclusión

Female patients presenting with Tanner breast stage 1 or 2 at age ≥ 13 years or male patients with testicular volume \< 5 cc at age ≥ 13.5 years, or who have had pubertal changes but have arrested pubertal development for a period of one year. Female patients presenting with primary amenorrhea (absence of menarche at age 15) \> 4 years after the onset of puberty or secondary amenorrhea \> 6 months with no other apparent cause (having ruled out other hormonal disorders such as premature ovarian failure, hypothyroidism, hyperprolactinemia, non-classical congenital adrenal hyperplasia, and polycystic ovary syndrome) may also be included. Patients with or without olfactory disorders, and with or without a previous diagnosis of other pituitary deficiencies will be included. In the case of a history of CNS tumor pathology, inclusion in this study will be considered only if the patient is in remission from the oncological disease and if they have received CNS radiotherapy, at least one year has passed since the beginning of the treatment.
If patients have started HRT, they may be included as long as they stop taking it for two half-lives of the compound used, therefore a 2-month free period is necessary for oral tablets or patches and 3 months for monthly testosterone injections or 7 months for testosterone undecanoate injections.

Criterios de exclusión

Patients will be excluded if, due to previous history or relevant clinical history or initial laboratory study, another cause is determined to explain their pubertal disorder: primary hypogonadism (hypergonadotrophic or premature ovarian failure), low weight with BMI \< 18, untreated hypothyroidism, hyperprolactinemia, hyperandrogenism, Cushing\'s syndrome, current prolonged corticosteroid treatment, active systemic disease, CRF or competitive training \> 10 hours/week, diabetes mellitus without adequate control or celiac disease without compliance with a gluten-free diet.
Patients who do not provide an updated medical history, who do not provide consent, or whose parents or guardians do not provide assent will be excluded. Patients who are receiving hormone replacement therapy and refuse to stop during the 2-month period for oral tablets or patches and 3 months for monthly testosterone injections or 7 months for quarterly depot injections of testosterone undecanoate will be excluded.

Intervenciones

diagnostic_test

Triptorelin (GnRH agonists)

1. Triptorelin test. A baseline blood sample will be taken to determine LH, FSH, Estradiol/Testosterone, AMH, and Inhibin B. Then, Triptorelin Acetate 100 ug/m² of body surface area will be administered subcutaneously, maximum dose 0.1 mg (Decapeptyl Daily prefilled syringe of 0.1 mg for subcutaneous administration. Three hours later, a new sample will be taken to determine LH and FSH. The patient may return home and lead a normal life. An appointment will be made the following day to perform the last sample of this test 24 hours after the subcutaneous administration of Triptorelin Acetate, with the determination of LH, FSH, Estradiol/Testosterone, and Inhibin B. 2. GnRH Infusion: This consists of determining LH and FSH in baseline blood samples, 15, 30, 45, 60 and 120 minutes after slow infusion of GnRH. GnRH 0.83 μg/min during the 120 minutes that the study lasts (Luteoliberin 100 μg)

Diagnóstico precoz del hipogonadismo hipogonadotrófico mediante una prueba de estimulación gonadotrófica-gonadal con agonista de GnRH (triptorelina)

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Triptorelin (GnRH agonists)

Ubicaciones

Hospital de Niños Dr. Ricardo Gutiérrez

Patrocinadores