Overview

Endometrial Markers and Response of Endometriosis Patients to Prolonged GnRH Agonist Prior to IVF

Status:
Completed
Trial end date:
2010-01-01
Target enrollment:
0
Participant gender:
Female
Summary
This prospective randomized trial evaluates whether one can predict which infertile women with endometriosis who are candidates for in vitro fertilization will benefit from prolonged therapy with a GnRH agonist by the determination of the absence of endometrial expression of the integrin, alpha v, beta 3 vitronectin. This is a prospective randomized trial in which all patients will undergo endometrial biopsy prior to initiation of ovarian stimulation for in vitro fertilization and then undergo randomization to a three month course of a depot preparation of the GnRH agonist leuprolide acetate in depot suspension prior to ovarian stimulation or standard therapy. prio
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Colorado Center for Reproductive Medicine
Treatments:
Leuprolide
Criteria
Inclusion Criteria:

- Infertility

- Surgical diagnosis of endometriosis

- Normal ovarian reserve testing

- Regular menses

Exclusion Criteria:

- Irregular menses

- Undiagnosed abnormal uterine bleeding

- Pregnancy

- Prior adverse reaction to any GnRH agonist

- Ovarian cystic or solid mass > 3cm in mean diameter at study entry

- Use of a depot preparation of a GnRh agonist or any hormonal therapy for endometriosis
within 6 months of study entry

- Current hepatic, renal, hematologic or psychiatric disorder