## Protocol Section
### Identification Module
**NCT ID:** 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.

#### Organization Study ID Info
**ID:** AMHunderGnRH
#### Organization
**Class:** OTHER
**Full Name:** University Magna Graecia
### Status Module
#### Completion Date
**Date:** 2014-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-11-25

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-11-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-10

**Type:** ACTUAL

#### Start Date
**Date:** 2014-03

**Status Verified Date:** 2014-11

#### Study First Post Date
**Date:** 2014-03-13
**Type:** ESTIMATED
**Study First Submit Date:** 2014-03-09
**Study First Submit QC Date:** 2014-03-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Magna Graecia

#### Responsible Party

**Investigator Affiliation:** University Magna Graecia

**Investigator Full Name:** Fulvio Zullo

**Investigator Title:** Full Professor Obstetric Gynecology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- 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

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 67

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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 Names:**

- Drug: GnRH analogue

**Label:** GnRH analogue

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- GnRH analogue

**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.

**Name:** GnRH analogue

**Other Names:**

- Gonadotropin-releasing hormone analogue

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** 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 Outcomes

**Measure:** 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

**Measure:** 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

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Catanzaro

**Country:** Italy

**Facility:** Chair of Obstetrics and Gynecology - University division - UMG

**State:** CZ

**Zip:** 88100

#### Overall Officials

**Official 1:**

**Affiliation:** Magna Graecia University of Catanzaro

**Name:** Fulvio Zullo

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009379

- Term: Neoplasms, Muscle Tissue

- ID: D000018204

- Term: Neoplasms, Connective and Soft Tissue

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000014591

- Term: Uterine Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M19918

- Name: Pelvic Pain

- Relevance: HIGH

- As Found: Pelvic Pain

- ID: M10901

- Name: Leiomyoma

- Relevance: HIGH

- As Found: Uterine Fibroids

- ID: M25846

- Name: Myofibroma

- Relevance: LOW

- As Found: Unknown

- ID: M7877

- Name: Endometriosis

- Relevance: HIGH

- As Found: Endometriosis

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M30012

- Name: Adenomyosis

- Relevance: HIGH

- As Found: Endometriosis of Uterus

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M20350

- Name: Neoplasms, Connective and Soft Tissue

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M17339

- Name: Uterine Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007889

- Term: Leiomyoma

- ID: D000004715

- Term: Endometriosis

- ID: D000062788

- Term: Adenomyosis

- ID: D000017699

- Term: Pelvic Pain

### Intervention Browse Module - Ancestors

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M9789

- Name: Hormones

- Relevance: HIGH

- As Found: Loss

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000006728

- Term: Hormones

### Misc Info Module

- Version Holder: 2024-05-24
