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

Colorado Center for Reproductive Medicine37 enrolled

Overview

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

See summary

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Endometriosis Infertility

Interventions

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 42 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Patients Who Responded to Controlled Ovarian Hyperstimulation

Number of patients who responded to controlled ovarian stimulation as evidenced by implantation of embryo. Implantation confirmed by ultrasound at 6 1/2 weeks of pregnancy.

Time frame: Evaluated at 6 1/2 weeks of pregnancy which is 4 weeks post embryo transfer.