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

Information source: Colorado Center for Reproductive Medicine
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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
Last updated: February 13, 2008

Page last updated: August 23, 2015

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