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

Tracking Information

First Received Date ^ICMJE

February 13, 2008

Last Updated Date

February 13, 2008

Start Date ^ICMJE

March 2003

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Do Endometrial Implantation Markers Predict in Vitro Fertilization-Embryo Transfer Cycle Outcomes in Endometriosis Patients Pretreated With Leuprolide Acetate in Depot Suspension?

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Endometriosis
Infertility

Intervention ^ICMJE

Drug: Leuprolide acetate in depot suspension
Drug: Leuprolide acetate
Drug: leuprolide acetate

Study Arms / Comparison Groups

Active Comparator: Positive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol
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
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
Active Comparator: Negative endometrial alpha v, beta 3 vitronectin expression and standard controlled ovarian stimulation protocol.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

21 Years to 42 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00621179

Responsible Party

Eric Surrey, M.D., Colorado Center for Reproductive Medicine

Study ID Numbers ^ICMJE

IntegrinIVF

Study Sponsor ^ICMJE

Colorado Center for Reproductive Medicine

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Eric S Surrey, M.D.

Colorado Center for Reproductive Medicine

Information Provided By

Colorado Center for Reproductive Medicine

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP