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

This study has been completed.
Sponsor:
Information provided by:
Colorado Center for Reproductive Medicine
ClinicalTrials.gov Identifier:
NCT00621179
First received: February 13, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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
Active Comparator: Group 1
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
Other Name: Lupron
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
Drug: Leuprolide acetate in depot suspension
Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3
Other Name: Depot Lupron
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
Other Name: 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 Name: Depot Lupron
Active Comparator: Group 4
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
Other Name: Lupron

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eric Surrey, M.D., Colorado Center for Reproductive Medicine
ClinicalTrials.gov Identifier: NCT00621179     History of Changes
Other Study ID Numbers: IntegrinIVF
Study First Received: February 13, 2008
Last Updated: February 13, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Colorado Center for Reproductive Medicine:
Endometriosis,infertility,in vitro fertilization

Additional relevant MeSH terms:
Endometriosis
Infertility
Genital Diseases, Female
Genital Diseases, Male
Leuprolide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014