Endometrial Markers and Response of Endometriosis Patients to Prolonged GnRH Agonist Prior to IVF
Information source: Colorado Center for Reproductive Medicine
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Endometriosis; Infertility
Intervention: Leuprolide acetate in depot suspension (Drug); Leuprolide acetate (Drug); leuprolide acetate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Colorado Center for Reproductive Medicine Official(s) and/or principal investigator(s):
Eric S Surrey, M.D., Principal Investigator, Affiliation: Colorado Center for Reproductive Medicine
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
Clinical Details
Official title: Do Endometrial Implantation Markers Predict in Vitro Fertilization-Embryo Transfer Cycle Outcomes in Endometriosis Patients Pretreated With Leuprolide Acetate in Depot Suspension?
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Primary outcome: Ongoing intrauterine pregnancy
Secondary outcome: Response to controlled ovarian hyperstimulation
Detailed description:
See summary
Eligibility
Minimum age: 21 Years.
Maximum age: 42 Years.
Gender(s): Female.
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
Locations and Contacts
Colorado Center for Reproductive Medicine, Lone Tree, Colorado 80124, United States
Additional Information
Related publications: Surrey ES, Silverberg KM, Surrey MW, Schoolcraft WB. Effect of prolonged gonadotropin-releasing hormone agonist therapy on the outcome of in vitro fertilization-embryo transfer in patients with endometriosis. Fertil Steril. 2002 Oct;78(4):699-704. Lessey BA, Castelbaum AJ, Sawin SW, Buck CA, Schinnar R, Bilker W, Strom BL. Aberrant integrin expression in the endometrium of women with endometriosis. J Clin Endocrinol Metab. 1994 Aug;79(2):643-9.
Starting date: March 2003
Ending date: February 2008
Last updated: February 13, 2008
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