Title
Endometrial Markers and Response of Endometriosis Patients to Prolonged GnRH Agonist Prior to IVF
Do Endometrial Implantation Markers Predict in Vitro Fertilization-embryo Transfer Cycle Outcomes in Endometriosis Patients Pretreated With Leuprolide Acetate in Depot Suspension?
Phase
Phase 4Lead Sponsor
Colorado Center for Reproductive MedicineStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Endometriosis InfertilityIntervention/Treatment
leuprolide ...Study Participants
37This 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
Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3
Positive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol followed by in vitro fertilization Intervention: No intervention
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
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
Negative endometrial alpha v, beta 3 vitronectin expression and standard controlled ovarian stimulation protocol followed by in vitro fertilization. Intervention: No intervention
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
| Event Type | Organ System | Event Term |
|---|
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.
