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AMH Levels Change During Treatment With GnRh Agonist

Primary Purpose

Uterine Fibroids, Endometriosis, Endometriosis of Uterus

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
GnRH analogue
Sponsored by
University Magna Graecia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Uterine Fibroids focused on measuring AMH levels, Ovarian reserve, GnRH analogue, Ovarian reserve after GnRH analogue, Ovarian reserve modification, Antral follicle count, Antral follicle count after GnRH analogue

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Chair of Obstetrics and Gynecology - University division - UMG

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

GnRH analogue

Arm Description

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

Outcomes

Primary Outcome Measures

AMH levels change before and after GnRHa

Secondary Outcome Measures

Preantral and antral follicles
Correlation between AMH levels and preantral and antral follicles count

Full Information

First Posted
March 9, 2014
Last Updated
November 22, 2014
Sponsor
University Magna Graecia
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1. Study Identification

Unique Protocol Identification Number
NCT02086279
Brief Title
AMH Levels Change During Treatment With GnRh Agonist
Official Title
AMH Levels Change During Treatment With GnRh Agonist: A Prospective Observational Study.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Magna Graecia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids, Endometriosis, Endometriosis of Uterus, Pelvic Pain
Keywords
AMH levels, Ovarian reserve, GnRH analogue, Ovarian reserve after GnRH analogue, Ovarian reserve modification, Antral follicle count, Antral follicle count after GnRH analogue

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GnRH analogue
Arm Type
No Intervention
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
GnRH analogue
Other Intervention Name(s)
Gonadotropin-releasing hormone analogue
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fulvio Zullo
Organizational Affiliation
Magna Graecia University of Catanzaro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chair of Obstetrics and Gynecology - University division - UMG
City
Catanzaro
State/Province
CZ
ZIP/Postal Code
88100
Country
Italy

12. IPD Sharing Statement

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AMH Levels Change During Treatment With GnRh Agonist

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