By means of this study we want to make statements regarding the effects of (high dose) radioiodine on male fertility, depicted by various fertility parameters (serum endocrine markers (LH and FSH), semen analyses and (conceived) pregnancy (outcomes…
ID
Source
Brief title
Condition
- Thyroid gland disorders
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Little is known about the long term treatment effects of radioiodine for
differentiated thyroid carcinoma (DTC) on male fertility. Transient impairment
of gonadal function is observed after single/low doses of radioiodine in males
treated for DTC. A dose-dependent effect of radioiodine on male fertility has
been described by serveral studies. However, especially the effects of
multiple/high radioiodine doses on long-term fertility remain unknown. Up to
now, only relatively short-term studies with a small number of participants
have been performed. The current study aims to evaluate long-term male
fertility after high dose administration of radioiodine for DTC.
Study objective
By means of this study we want to make statements regarding the effects of
(high dose) radioiodine on male fertility, depicted by various fertility
parameters (serum endocrine markers (LH and FSH), semen analyses and
(conceived) pregnancy (outcomes)). Sexual health will also be evaluated.
Thereby, we want to be able to form universal recommendation regarding the
management of male fertility after diagnosis of DTC.
Study design
This study is a multicenter cross-sectional study. All University Medical
Centers (UMCs) in the Netherlands are willing to participate in this study.
Patients will be evaluated from January 2017 to September 2019. Outpatient
evaluation will consist of semen analysis, serum sampling and filling in a
questionnaire. See also page 13 of the protocol.
Study burden and risks
Burden: males will undergo blood sampling (1x) and will be asked to fill out a
questionnaire (1x). In addition, patients will be asked to deliver a semen
sample for semen analysis (1x). We aim to schedule the examinations on the day
of an outpatient clinic visit. Medical chart evaluation will be performed and
does not cause any burden.
Benefits: survivors will be examined for possible late effects of radioiodine
on fertility and will be informed about their health status.
Risks: The process of semen delivery and serum sampling are without additional
risk for the patient, therefore, this study is without risks for participants.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59401.042.16 |