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Male fertility after treatment with radioiodine for differentiated thyroid carcinoma

Male fertility after treatment with radioiodine for differentiated thyroid carcinoma - Male fertility after DTC

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45710
Enrollment
100
Registered
2017-10-31
Start date
2017-09-05
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Differentiated thyroid carcinoma thyroid cancer

Interventions

Differentiated thyroid carcinoma
Late effects
Male fertility

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)