Male fertility is possibly impaired after treatment for differentiated thyroid carcinoma with a high dosis of radioactive iodine
ID
Bron
Verkorte titel
Aandoening
Differentiated thyroid cancer (DTC/Gedifferentieerd schildkliercarcinoom
Male fertility/Mannelijke fertiliteit
Radioactive iodine/Radioactie jodium
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Semen concentration
Achtergrond van het onderzoek
Little is known about the long term treatment effects of radioiodine for differentiated thyroid carcinoma (DTC) on male fertility. This study is a multicenter cross-sectional study. All University Medical Centers (UMCs) in the Netherlands are participating in this study. By means of this study we want to evaluate whether male fertility is impaired after treatment with radioiodine for DTC. All males (≥18 y) that were diagnosed with DTC and treated with a high cumulative dose of radioiodine (> 100 mCi/3.7 GBq) from 2008, at least ≥2 years after last administration of radioiodine are eligible for inclusion.
Evaluation consists of semen analysis, evaluation of levels of LH, FSH and free T and a questionnaire regarding fertility and sexuality.
Doel van het onderzoek
Male fertility is possibly impaired after treatment for differentiated thyroid carcinoma with a high dosis of radioactive iodine
Onderzoeksopzet
1
Onderzoeksproduct en/of interventie
not applicable
Publiek
Div Endocrinology
PO Box 30 001
T.P. Links
Groningen 9700 RB
The Netherlands
+31 (0)50 3613962/+31 (0)50 3616161
t.p.links@int.umcg.nl
Wetenschappelijk
Div Endocrinology
PO Box 30 001
T.P. Links
Groningen 9700 RB
The Netherlands
+31 (0)50 3613962/+31 (0)50 3616161
t.p.links@int.umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
All males (age ¡Ý 18y) diagnosed with DTC in the Netherlands from January 2008 that are at least ¡Ý2 years after their last treatment with a high cumulative dose of radioiodine (¡Ý 100 mCi/3.7 GBq) are eligible for inclusion.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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 (i.e. testosterone suppletion, chemotherapy);
- Use of anabolic steroids;
- Fever (body temperature >38¡ãC) 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;
or
- Non-compliance of thyroid hormone substitution, resulting in several measurements of TSH >10 mU/l in the last year before evaluation.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL5966 |
NTR-old | NTR6332 |
CCMO | NL59838.042.16 |
OMON | NL-OMON45389 |