Study on the fertility of women treated with triptorelin for precocious puberty in their childhood (PREFER)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Evaluation of fertility of women treated during their childhood for precocious puberty with triptorelin
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Longitudinal, prospective, descriptive, non-comparative epidemiological study

Population studied

• Short description of the study population:
  Women treated during childhood for precocious puberty with the Gonadotrophin Releasing Hormone (GnRH) analogue, triptorelin.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
• Special population of interest:
  Women of childbearing potential not using contraception

  Women of childbearing potential using contraception
• Estimated number of subjects:
  504

Study design details

• Main study objective:
  To analyse the fertility of women treated during childhood for precocious puberty with triptorelin.
• Outcomes:
  Fertility, • progress and outcome of the pregnancies, including the condition of the child at birth. • ovarian function and biometry of the women.• influence on fertility of the age at the time of diagnosis, etiology of precocious puberty, and treatment modalities. • socio-economic consequences of this condition (academic level, living conditions, occupation).
• Data analysis plan:
  • Description of the population included• Checking for biases by comparing the major data of the included patients with those of patients who could not be found or refused to participate in the study (data processing being totally anonymous)• Analysis of risk factors for the primary and secondary endpoints • Patient characteristics: age, age at diagnosis, seriousness of precocious puberty, weight, etc. • Characteristics of the treatment for precocious puberty: duration, doses, concomitant treatments in addition to triptorelin, e.g. medroxyprogesterone or cyproterones• Comparison of the pregnancy rate observed in women trying to conceive with the theoretical rate of the general population (85%)