AMH Levels Change During Treatment With GnRh Agonist

NCT02086279 | Completed DMC

• 1 other identifier: AMHunderGnRH
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• AMH levels change before and after GnRHa

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

Secondary Outcomes (2)

• Preantral and antral follicles

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

• 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

Study Arms (1)

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

Drug: GnRH analogue

Interventions

GnRH analogue DRUG

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.

Also known as: Gonadotropin-releasing hormone analogue

GnRH analogue

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• to 45 years aged patients
• Regular menstrual intervals between 22 and 35 days
• Expressed written consent for the study entry

You may not qualify if:

• 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

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

Chair of Obstetrics and Gynecology - University division - UMG

Catanzaro, CZ, 88100, Italy

Location

MeSH Terms

Conditions

Leiomyoma; Endometriosis; Adenomyosis; Pelvic Pain

Interventions

Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Fulvio Zullo

  Magna Graecia University of Catanzaro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor Obstetric Gynecology

Study Record Dates

• First Submitted: March 9, 2014
• First Posted: March 13, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 25, 2014

Record last verified: 2014-11

Locations

IT (1)