Male fertility after treatment with radioiodine for differentiated thyroid carcinoma

Completed

Conditions: Differentiated thyroid carcinoma
thyroid cancer
10043739
10013356

Registration Number: NL-OMON45710

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

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

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the semen concentration measured in the ejaculate<br /><br>of the participating males.<br /><br>Other main study parameters are:<br /><br>- Semen quality, measured by means of the following parameters:<br /><br>- Volume<br /><br>- Concentration<br /><br>- Motility<br /><br>- Morphology<br /><br>- VCM<br /><br>- pH<br /><br>- Serum endocrine markers:<br /><br>- LH<br /><br>- FSH<br /><br>- FreeT</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are:<br /><br>- Conceived pregnancies/pregnancy complications/congenital malformations in<br /><br>children<br /><br>- Ongoing pregnancy (>12 weeks) and live birth rate<br /><br>- Data regarding semen quality before radioiodine administration<br /><br>- Serum: TSH en FT4<br /><br>- Sexual health, defined by sexual satisfaction and sexual functioning,<br /><br>whether or not combined with quality of life</p><br>