Ignite Creation Date:
2024-05-06 @ 2:00 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04189406
Status:
RECRUITING
Last Update Posted:
2023-11-29
First Post:
2019-11-25
Brief Title:
Turner Syndrome Minipuberty Study
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Turner Syndrome Minipuberty Study A Prospective Descriptive Cohortstudy
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Minipuberty
Brief Summary:
Rationale Due to accelerated germ cell loss infertility is a major problem in girls with Turner syndrome TS Therefore cryopreservation of ovarian tissue or oocytes before exhaustion of the ovarian reserve may preserve fertility in patients with TS However in the majority of females with TS the ovarian reserve is exhausted before the age of menarche Early markers indicating and predicting the ovarian reserve are necessary During mid-childhood the hypothalamic-pituitary-gonadal HPG axis is quiescent and gonadotropins are usually unmeasurable Nonetheless this axis is active during infancy Therefore gonadotropins are measurable with peak values at 3 months of age and with lower but still measurable values at 9 months of age in a period called the minipuberty The aim of this study is to find markers of ovarian capacity during the minipuberty in order to predict ovarian reserve in the future
Objective The hormonal range of LH FSH AMH inhibin B testosterone and estradiol in girls with TS during the minipuberty and the relation of the hormone serum levels with the karyotype
Study design A prospective cohort study with a duration of 3 years Study population Girls with a pre- or perinatal diagnosis TS who are born in a medical centre in the Netherlands during the duration of the study
Main study parametersendpoints Serum levels of FSH LH AMH inhibin B testosterone and estradiol at the age of 3 and 9 months
Objective The hormonal range of LH FSH AMH inhibin B testosterone and estradiol in girls with TS during the minipuberty and the relation of the hormone serum levels with the karyotype
Study design A prospective cohort study with a duration of 3 years Study population Girls with a pre- or perinatal diagnosis TS who are born in a medical centre in the Netherlands during the duration of the study
Main study parametersendpoints Serum levels of FSH LH AMH inhibin B testosterone and estradiol at the age of 3 and 9 months
Detailed Description:
Nature and extent of the burden and risks associated with participation benefit and group relatedness
The subjects will have twice an extra venapunction for collection of 35mL blood during their infancy which is not stated in the guidelines for TS There is very little risk for adverse events associated with this blood sample collection however it is an extra procedure The outcome parameters will not be helpful for individual study participants however they are likely to help clinicians and researchers in understanding how the ovarian function operates develops in girls with TS Furthermore these markers could be used to estimate the ovarian reserve and the urgency of fertility preservation in young females with TS This information could help clinicians patients and their parents in decision making
The subjects will have twice an extra venapunction for collection of 35mL blood during their infancy which is not stated in the guidelines for TS There is very little risk for adverse events associated with this blood sample collection however it is an extra procedure The outcome parameters will not be helpful for individual study participants however they are likely to help clinicians and researchers in understanding how the ovarian function operates develops in girls with TS Furthermore these markers could be used to estimate the ovarian reserve and the urgency of fertility preservation in young females with TS This information could help clinicians patients and their parents in decision making
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None