Do Endometrial Implantation Markers Predict in Vitro Fertilization-embryo Transfer Cycle Outcomes in Endometriosis Patients Pretreated With Leuprolide Acetate in Depot Suspension?
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Patients Who Responded to Controlled Ovarian Hyperstimulation
Study Overview
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
Detailed Description
See summary
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 42 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group 1
Positive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol followed by in vitro fertilization Intervention: No intervention
Intervention: No intervention (Other)
Group 2
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
Intervention: Leuprolide acetate in depot suspension (Drug)
Group 3
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
Intervention: Leuprolide acetate in depot suspension (Drug)
Group 4
Negative endometrial alpha v, beta 3 vitronectin expression and standard controlled ovarian stimulation protocol followed by in vitro fertilization. Intervention: No intervention
Intervention: No intervention (Other)
Outcomes
Primary Outcomes
Patients Who Responded to Controlled Ovarian Hyperstimulation
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Eric Surrey, M.D.
Medical Director
Colorado Center for Reproductive Medicine