AMH Levels Change During Treatment With GnRh Agonist
Condition: Uterine Fibroids; Endometriosis; Endometriosis of Uterus; Pelvic Pain
MeSH terms: Leiomyoma; Endometriosis; Adenomyosis; Pelvic Pain
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): GnRH analogue
Intervention type(s): Drug
Intervention description(s): Patients with uterine myoma, endometriosis, fibromatous uterus, chronic pelvic pain in list for laparoscopic surgery or laparotomy are usually pharmacologically treated by administration of GnRHa, 11.25 mg at 21° day of the menstrual cycle and repeated after 3 months. This treatment is part of our preoperative routine in order to reduce pain symptoms, menstrual blood loss, uterine or fibroids vascularization and size, during the months spent on surgery waiting list.
Patients who will satisfy inclusion and exclusion criteria will be enrolled in this study protocol and will be subjected to valuation of ovarian reserve: specifically, serum levels of AMH and antral follicle count (AFC) between first and fourth days of the menstrual cycle will be measured.
Other intervention name(s): Gonadotropin-releasing hormone analogue
Intervention MeSH terms: Hormones
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: AMH levels; Ovarian reserve; GnRH analogue; Ovarian reserve after GnRH analogue; Ovarian reserve modification; Antral follicle count; Antral follicle count after GnRH analogue