No registrations found.
ID
Source
Brief title
Health condition
Differentiated thyroid cancer (DTC/Gedifferentieerd schildkliercarcinoom
Male fertility/Mannelijke fertiliteit
Radioactive iodine/Radioactie jodium
Sponsors and support
Intervention
Outcome measures
Primary outcome
Semen concentration
Secondary outcome
Semen quality, measured by means of the following parameters:
- Volume
- Concentration
- Motility
- Morphology
- VCM
- pH
- Serum endocrine markers:
- LH
- FSH
- Free T
- Conceived pregnancies/pregnancy complications/congenital malformations in children
- Ongoing pregnancy (>12 weeks) and live birth rate
- Data regarding semen quality before radioiodine administration
- Number of patients performing semen preservation and subsequent usage rate
- To evaluate sexual health in males treated with radioiodine for DTC.
Background summary
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.
Study objective
Male fertility is possibly impaired after treatment for differentiated thyroid carcinoma with a high dosis of radioactive iodine
Study design
1
Intervention
not applicable
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
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
Inclusion criteria
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.
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 (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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5966 |
| NTR-old | NTR6332 |
| CCMO | NL59838.042.16 |
| OMON | NL-OMON45389 |