Clinical trial NCT00621179: Endometrial Markers and Response of Endometriosis Patients to Prolonged GnRH Agonist Prior to IVF
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endometriosis
Infertility
Keywords: Endometriosis,infertility,in vitro fertilization
Lead sponsor: Colorado Center for Reproductive Medicine
Sponsor class: OTHER
First posted: 2008-02-22
Enrollment: 37
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Patients Who Responded to Controlled Ovarian Hyperstimulation
timeFrame: Evaluated at 6 1/2 weeks of pregnancy which is 4 weeks post embryo transfer.
Secondary outcomes:
Other outcomes:
Locations:
city: Lone Tree
country: United States
facility: Colorado Center for Reproductive Medicine
state: Colorado
Study officials:
affiliation: Colorado Center for Reproductive Medicine
name: Eric S Surrey, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/s0015-0282(02)03373-3.
citation: 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. doi: 10.1210/jcem.79.2.7519194.
citation: Surrey ES, Lietz AK, Gustofson RL, Minjarez DA, Schoolcraft WB. Does endometrial integrin expression in endometriosis patients predict enhanced in vitro fertilization cycle outcomes after prolonged GnRH agonist therapy? Fertil Steril. 2010 Feb;93(2):646-51. doi: 10.1016/j.fertnstert.2008.12.023. Epub 2009 Jan 26.