fertility gondal function
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: Children (
Exclusion criteria
Exclusion criteria: no informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In girls, the primary outcome measure is AMH. In all treatment arms, the distribution of serum AMH level (corrected for age, as AMH rises with age, sd z-scores will be calculated to correct (16) directly after chemotherapy and at two years, will be compared to the distribution at baseline level, using a Wilcoxon signed-rank test. If the data are normally distributed, a paired sample t-test will be used. Next, the Kruskal-Wallis test will be used to compare the distributions of the change of AMH level (directly after chemotherapy compared to baseline), between all three treatment arms. If there is a significant difference between the arms, a Mann-Whitney U test with Bonferroni multiple testing correction will be applied as post-hoc test. If the data are normally distributed a one-way analysis of variance and two-sample t-tests with Bonferroni correction as a posthoc test, might be used instead. This analysis is repeated for the two years measurement. To test the gonadotoxic effect of the intensified (DECOPDAC) chemotherapy, the distributions of the change of AMH after chemotherapy (compared to baseline) for the COPDAC- and the DECOPDAC-treatment groups will be compared in both TL2 and TL3, using the Mann-Whitney U test or a two-sample t-test in case of normality. This analysis is repeated for the two years measurement. In boys the primary outcome measure is semen (TMSC, total motile sperm count = volume ejaculate (ml) x sperm concentration x progressive motility in % (31)). For this outcome measure an identical statistical analysis will performed as in girls. For the tests a significance level of 0.05 is used. | — |
Secondary
| Measure | Time frame |
|---|---|
| In girls, amenorrhea and changed menstrual cycle (both dichotomous) will be used as secondary outcome measures. For all arms the fractions of girls with amenorrhea or a changed menstrual cycle will be estimated. In boys, Inhibin B, expressed continuously in pg/ml, and FSH expressed in U/l will be measured. Changes within individuals during follow-up will be assessed. Other study parameters In girls, ovarian volume as well as uterus dimensions (max length and max width) will be In girls, ovarian volume as well as uterus dimensions (max length and max width) will be assessed retrospectively from MRI*s that are performed in the context of patient care. In boys, these MRI*s will be used to measure testicular volume. In a subset of patients, patient and parental experience on fertility care and fertility counseling will be collected using a questionnaire during follow up. | — |
Countries
Netherlands
Outcome results
None listed