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

Phase 4

Completed

Interventions: Other: No intervention
Drug: Leuprolide acetate in depot suspension

Brief 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

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Group 1	No intervention	Positive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol followed by in vitro fertilization Intervention: No intervention
Group 4	No intervention	Negative endometrial alpha v, beta 3 vitronectin expression and standard controlled ovarian stimulation protocol followed by in vitro fertilization. Intervention: No intervention
Group 2	Leuprolide acetate in depot suspension	Intervention: Positive endometrial alpha v beta 3 vitronectin expression, 3 months of leuprolide acetate in depot suspension administration prior to initiation of controlled ovarian stimulation followed by in vitro fertilization
Group 3	Leuprolide acetate in depot suspension	Negative endometrial alpha v, beta 3 vitronectin and administration of leuprolide acetate in depot suspension for 3 months prior to initiation of controlled ovarian stimulation

Primary Outcome Measures

Name	Time	Method
Patients Who Responded to Controlled Ovarian Hyperstimulation	Evaluated at 6 1/2 weeks of pregnancy which is 4 weeks post embryo transfer.	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.

Secondary Outcome Measures