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Mannelijke vruchtbaarheid na een hoge dosis radioactief jodium voor de behandeling van gedifferentieerd schildklierkanker


- candidate number27180
- NTR NumberNTR6332
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-mei-2017
- Secondary IDsNL59838.042.16 MEC
- Public TitleMannelijke vruchtbaarheid na een hoge dosis radioactief jodium voor de behandeling van gedifferentieerd schildklierkanker
- Scientific TitleMale fertility after treatment with a high dose radioiodine for differentiated thyroid carcinoma
- ACRONYMMATTER
- hypothesisMale fertility is possibly impaired after treatment for differentiated thyroid carcinoma with a high dosis of radioactive iodine
- Healt Condition(s) or Problem(s) studiedDifferentiated thyroid carcinoma, Radioactive iodine, Male fertilization
- Inclusion criteriaAll males (age 18y) diagnosed with DTC in the Netherlands from January 2008 that are at least 2 years after their last treatment with a high cumulative dose of radioiodine ( 100 mCi/3.7 GBq) are eligible for inclusion.
- Exclusion criteriaA 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 >38C) 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 15-mei-2017
- planned closingdate9-sep-2019
- Target number of participants100
- Interventionsnot applicable
- Primary outcomeSemen concentration
- Secondary outcomeSemen 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.
- Timepoints1
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. T.P. Links
- CONTACT for SCIENTIFIC QUERIESDr. T.P. Links
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
UMCG Kanker Researchfonds
- Publications
- Brief summaryLittle 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.
- Main changes (audit trail)
- RECORD9-mei-2017 - 28-mei-2017


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