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.
ID
Source
Brief title
Condition
- Reproductive tract and breast disorders congenital
- Endocrine disorders of gonadal function
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Serum levels of FSH, LH, AMH, estradiol, inhibin B and testosterone.
Secondary outcome
-
Background summary
Due to accelerated germ cell loss, infertility is a major problem in girls with
Turner syndrom (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.
Study 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 burden and risks
The subjects will have the burden of an extra venapuncture (girls with TS) or
extra blood tube (controls) of 3.5 mL blood during their infancy. Venapunction
is done during a regular outpatient visit to the hospital. There is very little
risk for adverse events associated with this blood sample collection itself.
Adverse events that could be associated with an extra venapunction during a
normal collection of blood are pain during the procedure and bruising. It could
also cause psychological stress to the parents when they see the venapunction
at their daughter. To minimise these adverse events, the procedure will be done
by an experienced nurse and will be monitored closely. Furthermore, the burden
on the parents and their daughter will be minimised by conducting the
venapunction during a regular, outpatient visit within the usual care.
The information from these blood samples will be available to the parents (and
later also to the girl) through their electronic patient record. A disclaimer
on this information will be added to the information in the record, which will
state: *The values of these hormones are taken in a study context and it is not
known what they indicate about the fertility chances of your daughter. You can
ask any questions about these values to your usual caregiver.* In the future,
these markers might be able to support the counseling for possible fertility
preservation in young girls with TS. Especially, they might become of
importance in the considerations around performing cryopreservation of ovarian
tissue and in the prospects regarding pubertal development.
This study can only be performed in girls with TS because they show a specific
pattern of gonadal dysfunction. This study cannot be performed at a later age
since the minipuberty is strictly related to the infancy period.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in the TS group of this study, a subject
must meet all of the following criteria:
- A diagnosis of TS before the age of three months;
- Girls with a diagnosis of classic TS or other variants (i.e. 45,X,
45,X/46XiXq, 45,X/46,XY, 45,X/46,XX, 45,X/47,XXX, 45,X/46,X,r(X), 46,XiXq,
other);
- Whose parents have agreed to participate in the study through a signed
written informed consent form.
In order to be eligible to participate in the control group of this study, a
subject must meet all of the following criteria:
- No diagnosis of TS or any other diagnosis that might affect the HPG axis;
- Girls that will have a blood collection within their usual care at 3 months
and at 9 months of age.
- Whose parents have agreed to participate in the study through a signed
informed consent form.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Any other diagnosis besides TS that might affect the HPG axis;
- Ovarian surgery in the medical history;
- Critical illness;
- The use of medication affecting the HPG axis (e.g. estrogen suppletion
therapy)
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 |
|---|---|
| ClinicalTrials.gov | NCT04189406 |
| CCMO | NL72128.091.20 |