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AMH Levels Change During Treatment With GnRh Agonist

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ClinicalTrials.gov Identifier: NCT02086279
Recruitment Status : Completed
First Posted : March 13, 2014
Last Update Posted : November 25, 2014
Sponsor:
Information provided by (Responsible Party):
Fulvio Zullo, University Magna Graecia

Brief 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).

Condition or disease Intervention/treatment Phase
Uterine Fibroids Endometriosis Endometriosis of Uterus Pelvic Pain Drug: GnRH analogue Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: AMH Levels Change During Treatment With GnRh Agonist: A Prospective Observational Study.
Study Start Date : March 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: GnRH analogue

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

Drug: GnRH analogue

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 Name: Gonadotropin-releasing hormone analogue




Primary Outcome Measures :
  1. AMH levels change before and after GnRHa [ Time Frame: At study entry and at 1, 3 and 6 months after the administration of the first vial of GnRH-a ]

Secondary Outcome Measures :
  1. Preantral and antral follicles [ Time Frame: At study entry and at 1, 3 and 6 months after the administration of the first vial of GnRH-a ]
  2. Correlation between AMH levels and preantral and antral follicles count [ Time Frame: At study entry and at 1,3 and 6 months after the first vial of GnRH ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086279


Locations
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Italy
Chair of Obstetrics and Gynecology - University division - UMG
Catanzaro, CZ, Italy, 88100
Sponsors and Collaborators
University Magna Graecia
Investigators
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Principal Investigator: Fulvio Zullo Magna Graecia University of Catanzaro

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Responsible Party: Fulvio Zullo, Full Professor Obstetric Gynecology, University Magna Graecia
ClinicalTrials.gov Identifier: NCT02086279     History of Changes
Other Study ID Numbers: AMHunderGnRH
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: November 25, 2014
Last Verified: November 2014

Keywords provided by Fulvio Zullo, University Magna Graecia:
AMH levels
Ovarian reserve
GnRH analogue
Ovarian reserve after GnRH analogue
Ovarian reserve modification
Antral follicle count
Antral follicle count after GnRH analogue

Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Endometriosis
Adenomyosis
Pelvic Pain
Genital Diseases, Female
Pain
Neurologic Manifestations
Signs and Symptoms
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Diseases
Deslorelin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action