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

August 6, 2021 updated by: Eric Surrey, M.D., Colorado Center for Reproductive Medicine

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See summary

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Positive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol followed by in vitro fertilization Intervention: No intervention
Other: No intervention
Experimental: Group 2
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
Drug: Leuprolide acetate in depot suspension
Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3
Other Names:
  • Depot Lupron
Experimental: Group 3
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
Other Names:
  • Depot Lupron
Active Comparator: Group 4
Negative endometrial alpha v, beta 3 vitronectin expression and standard controlled ovarian stimulation protocol followed by in vitro fertilization. Intervention: No intervention
Other: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients Who Responded to Controlled Ovarian Hyperstimulation
Time Frame: Evaluated at 6 1/2 weeks of pregnancy which is 4 weeks post embryo transfer.
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.
Evaluated at 6 1/2 weeks of pregnancy which is 4 weeks post embryo transfer.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colorado Center for Reproductive Medicine

Investigators

  • Principal Investigator: Eric S Surrey, M.D., Colorado Center for Reproductive Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

February 13, 2008

First Submitted That Met QC Criteria

February 13, 2008

First Posted (Estimate)

February 22, 2008

Study Record Updates

Last Update Posted (Actual)

August 10, 2021

Last Update Submitted That Met QC Criteria

August 6, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IntegrinIVF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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