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临床试验/NCT02086279
NCT02086279已完成不适用

AMH Levels Change During Treatment With GnRh Agonist: A Prospective Observational Study.

University Magna Graecia1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
67
试验地点
1
主要终点
AMH levels change before and after GnRHa

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients waiting for surgery for benign conditions such as uterine fibroids and endometriosis, undergoing preoperative treatment with two consecutive doses of GnRHa at a dose of 11.25 every three months
  • 18 to 45 years aged patients
  • Regular menstrual intervals between 22 and 35 days
  • Expressed written consent for the study entry

排除标准

  • Patients who do not consent to pharmacological preparation with GnRHa
  • Estrogen-progestin therapy in the 2 months before enrollment
  • Autoimmune diseases, chronic , metabolic, systemic and endocrine disorders, including hyperandrogenism, hyperprolactinemia, diabetes mellitus and thyroid disease.
  • Hypogonadotropic hypogonadism
  • Majors clinical conditions

研究组 & 干预措施

GnRH analogue

No Intervention

Patients with uterine myoma, endometriosis, fibromatous uterus, chronic pelvic pain in list for surgery are usually pharmacologically treated by administration of GnRHa, 11.25 mg at 21° day of the menstrual cycle and repeated after 3 months to reduce pain symptoms, menstrual blood loss, uterine or fibroids vascularization and size, during the months spent on surgery waiting list.

Patients enrolled will be subjected to valuation of ovarian reserve: specifically, serum levels of AMH and antral follicle count (AFC) between 1 and 4 days of the menstrual cycle will be measured at study entry and at 1, 3 and 6 months after the administration of the first vial of GnRH-a

干预措施: GnRH analogue (Drug)

结局指标

主要结局

AMH levels change before and after GnRHa

时间窗: At study entry and at 1, 3 and 6 months after the administration of the first vial of GnRH-a

次要结局

  • Correlation between AMH levels and preantral and antral follicles count(At study entry and at 1,3 and 6 months after the first vial of GnRH)
  • Preantral and antral follicles(At study entry and at 1, 3 and 6 months after the administration of the first vial of GnRH-a)

研究者

发起方
University Magna Graecia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fulvio Zullo

Full Professor Obstetric Gynecology

University Magna Graecia

研究点 (1)

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