Endometrial Markers and Response of Endometriosis Patients to Prolonged GnRH Agonist Prior to IVF - Full Text View

Sponsored by:	Colorado Center for Reproductive Medicine
Information provided by:	Colorado Center for Reproductive Medicine
ClinicalTrials.gov Identifier:	NCT00621179

Purpose

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

Condition	Intervention	Phase
Endometriosis Infertility	Drug: Leuprolide acetate in depot suspension Drug: Leuprolide acetate Drug: leuprolide acetate	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Do Endometrial Implantation Markers Predict in Vitro Fertilization-Embryo Transfer Cycle Outcomes in Endometriosis Patients Pretreated With Leuprolide Acetate in Depot Suspension?

Resource links provided by NLM:

MedlinePlus related topics: Endometriosis Infertility

Drug Information available for: Leuprolide Leuprolide acetate

U.S. FDA Resources

Further study details as provided by Colorado Center for Reproductive Medicine:

Primary Outcome Measures:

Ongoing intrauterine pregnancy [ Time Frame: 6-8 weeks after embryo transfer ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response to controlled ovarian hyperstimulation [ Time Frame: Evaluated at time of embryo transfer ] [ Designated as safety issue: No ]

Enrollment:	37
Study Start Date:	March 2003
Study Completion Date:	February 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Active Comparator Positive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol	Drug: leuprolide acetate Leuprolide acetate 20 mcg subcutaneously twice daily or 0.5 mg subcutaneously once daily prior to initiation of gonadotropin stimulation
Group 2: Experimental 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	Drug: Leuprolide acetate in depot suspension Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3 Drug: Leuprolide acetate leuprolide acetate 20 mcg subcutaneously twice daily for two days or 0.5 mg daily for 7 days prior to initiation of controlled ovarian stimulation
Group 3: Experimental 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	Drug: Leuprolide acetate in depot suspension Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3
Group 4: Active Comparator Negative endometrial alpha v, beta 3 vitronectin expression and standard controlled ovarian stimulation protocol.	Drug: leuprolide acetate Leuprolide acetate 20 mcg subcutaneously twice daily or 0.5 mg subcutaneously once daily prior to initiation of gonadotropin stimulation

Detailed Description:

See summary

Eligibility

Ages Eligible for Study:	21 Years to 42 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621179

Locations

United States, Colorado
Colorado Center for Reproductive Medicine
Lone Tree, Colorado, United States, 80124

Sponsors and Collaborators

Colorado Center for Reproductive Medicine

Investigators

Principal Investigator:

Eric S Surrey, M.D.

Colorado Center for Reproductive Medicine

More Information

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.

Responsible Party:	Colorado Center for Reproductive Medicine ( Eric Surrey, M.D. )
Study ID Numbers:	IntegrinIVF
Study First Received:	February 13, 2008
Last Updated:	February 13, 2008
ClinicalTrials.gov Identifier:	NCT00621179 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Colorado Center for Reproductive Medicine:

Endometriosis,infertility,in vitro fertilization

Study placed in the following topic categories:

Genital Diseases, Female
Deslorelin
Infertility
Antineoplastic Agents, Hormonal

Leuprolide
Endometriosis
Genital Diseases, Male

Additional relevant MeSH terms:

Infertility
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Endometriosis
Reproductive Control Agents
Genital Diseases, Male

Pharmacologic Actions
Genital Diseases, Female
Leuprolide
Therapeutic Uses
Fertility Agents, Female
Fertility Agents

ClinicalTrials.gov processed this record on July 06, 2009