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

Primary Purpose

Endometriosis, Infertility

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Leuprolide acetate in depot suspension
No intervention
Sponsored by
Colorado Center for Reproductive Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Endometriosis,infertility,in vitro fertilization

Eligibility Criteria

21 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Colorado Center for Reproductive Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Positive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol followed by in vitro fertilization Intervention: No intervention

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 followed by in vitro fertilization

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

Negative endometrial alpha v, beta 3 vitronectin expression and standard controlled ovarian stimulation protocol followed by in vitro fertilization. Intervention: No intervention

Outcomes

Primary Outcome Measures

Patients Who Responded to Controlled Ovarian Hyperstimulation
Number of patients who responded to controlled ovarian stimulation as evidenced by implantation of embryo. Implantation confirmed by ultrasound at 6 1/2 weeks of pregnancy.

Secondary Outcome Measures

Full Information

First Posted
February 13, 2008
Last Updated
August 6, 2021
Sponsor
Colorado Center for Reproductive Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00621179
Brief Title
Endometrial Markers and Response of Endometriosis Patients to Prolonged GnRH Agonist Prior to IVF
Acronym
IntegrinIVF
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Colorado Center for Reproductive Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Infertility
Keywords
Endometriosis,infertility,in vitro fertilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Positive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol followed by in vitro fertilization Intervention: No intervention
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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 followed by in vitro fertilization
Arm Title
Group 3
Arm Type
Experimental
Arm Description
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
Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
Negative endometrial alpha v, beta 3 vitronectin expression and standard controlled ovarian stimulation protocol followed by in vitro fertilization. Intervention: No intervention
Intervention Type
Drug
Intervention Name(s)
Leuprolide acetate in depot suspension
Other Intervention Name(s)
Depot Lupron
Intervention Description
Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3
Intervention Type
Other
Intervention Name(s)
No intervention
Primary Outcome Measure Information:
Title
Patients Who Responded to Controlled Ovarian Hyperstimulation
Description
Number of patients who responded to controlled ovarian stimulation as evidenced by implantation of embryo. Implantation confirmed by ultrasound at 6 1/2 weeks of pregnancy.
Time Frame
Evaluated at 6 1/2 weeks of pregnancy which is 4 weeks post embryo transfer.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric S Surrey, M.D.
Organizational Affiliation
Colorado Center for Reproductive Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado Center for Reproductive Medicine
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12372443
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.
Results Reference
background
PubMed Identifier
7519194
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.
Results Reference
background
PubMed Identifier
19171333
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.
Results Reference
derived

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

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