Endometriosis Clinical Trial
Official title:
AMH Levels Change During Treatment With GnRh Agonist: A Prospective Observational Study.
To evaluate the variation of AMH levels in women undergoing treatment with GnRHa, and to assess whether this variation correlates with changes in the antral and pre-antral follicle ultrasonographic count (AFC).
The anti Mullerian hormone (AMH) is a glycoprotein produced by granulosa cells of antral and
preantral ovarian follicles.
Several studies have shown that the AMH levels provide a reliable indication of the size of
the growing follicles pool (1). AMH is now commonly used as a biomarker for improving the
ovarian reserve in women of reproductive age because it is related with outcomes of assisted
reproduction cycles, chances of pregnancy and distance from menopause (2-4).
For several years GnRH agonists have been used for the purpose of preserving fertility in
the course of chemotherapy in young women with cancer (5). Their effectiveness, however,
isn't 100% and there is the need to monitor the ovarian reserve in the course of treatment
in these young women. With the administration of GnRHa, the FSH levels (the most used
hormone for improve the ovarian reserve, although it is less reliable and less manageable
because of its intra-cyclic variations) cannot be used to measure the residual ovarian
function due to the physiological reduction of gonadotropins induced by the treatment. AMH
levels, conversely, are relatively stable both during the menstrual cycle (6) and during
administration of the contraceptive pill (7,8), suggesting the gonadotrophin independence of
this molecule. AMH could therefore be a useful biomarker of ovarian reserve in the course of
GnRHa treatment.
The use of GnRHa for fertility preservation during chemotherapy is controversial because of
inconclusive outcome data on fertility (9) and because the mechanism by which GnRHa may act
to preserve fertility is unknown. The major function of GnRHa is to suppress the production
of pituitary gonadotrophins, acting indirectly on the ovarian follicles, not exposing
growing follicles to the toxicity of chemotherapy and thus protecting the future ovarian
function.
Determine the effect of GnRHa on AMH serum level is an essential step to determine both the
effectiveness of the treatment in terms of preservation of fertility and the reliability of
this marker for ovarian reserve in cancer patients treated with GnRHa. Up to now, the
published studies have shown extremely contrasting data. Considered that GnRHa is largely
used in non-oncological patients for preoperative pharmacological preparation in various
benign gynecological conditions, it is possible to exploit the high number of patients with
these characteristics for the non-invasive assessment of analogue effect on the AMH levels.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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