Differentiated thyroid carcinoma thyroid cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: All males (age * 18) that were diagnosed with DTC and treated with radioiodine after 2000 that are at least *2 years after their last treatment with a high cumulative dose of radioiodine (* 100 mCi) are eligible for inclusion for this study
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Use of drugs that interact with semen quality - Use of anabolic steroids - Fever (body temperature >38°C) in the three months before semen analysis - Gonadal/testicular diseases or treatments that are associated with impairment of semen quality - Active disease state (widespread metastases, under active treatment for DTC or active treatment with systemic therapy/radiotherapy). - Attained age older than 60 years. - I-131 only administered combined with use of recombinant human TSH (rhTSH) and no thyroid hormone withdrawal therapy before I-131 administrations; - Non-compliance of thyroid hormone substitution, resulting in several measurements of TSH >10 mU/l in the last year before evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the semen concentration measured in the ejaculate of the participating males. Other main study parameters are: - Semen quality, measured by means of the following parameters: - Volume - Concentration - Motility - Morphology - VCM - pH - Serum endocrine markers: - LH - FSH - FreeT | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters are: - Conceived pregnancies/pregnancy complications/congenital malformations in children - Ongoing pregnancy (>12 weeks) and live birth rate - Data regarding semen quality before radioiodine administration - Serum: TSH en FT4 - Sexual health, defined by sexual satisfaction and sexual functioning, whether or not combined with quality of life | — |
Countries
The Netherlands