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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

Short name IntegrinIVF

NCTNCT00621179 (opens ClinicalTrials.gov in a new tab)Other idIntegrinIVF
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
37 participants (actual)
Sponsor
Colorado Center for Reproductive Medicine · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Mar 2003
Primary completion
Aug 2009
Completion
Jan 2010
First posted
22 Feb 2008 (estimated)
Last update posted
10 Aug 2021
Conditions
Endometriosis · Infertility

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2004200620082010
  1. Ph 4

    IntegrinIVF

    NCT00621179

    Mar 2003 to Jan 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Leuprolide acetate in depot suspensionDrug
  • No interventionOther

Arms4

  • 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

  • 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

  • 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

  • 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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Patients Who Responded to Controlled Ovarian Hyperstimulation

    Time frame · Evaluated at 6 1/2 weeks of pregnancy which is 4 weeks post embryo transfer.

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Evaluated at 6 1/2 weeks of pregnancy which is 4 weeks post embryo transfer.

Patients Who Responded to Controlled Ovarian Hyperstimulation

GroupValue (Participants)
Group 17
Group 25
Group 33
Group 45

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Group 1Positive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol0 / 120 / 120 / 12
Group 2Intervention: Positive endometrial alpha v beta 3 vitronectin expression, 3 months of leuprolide acetate in depot suspension administration prior to initiation of controlled ovarian stimulation0 / 80 / 80 / 8
Group 3Negative endometrial alpha v, beta 3 vitronectin and administration of leuprolide acetate in depot suspension for 3 months prior to initiation of controlled ovarian stimulation0 / 70 / 70 / 7
Group 4Negative endometrial alpha v, beta 3 vitronectin expression and standard controlled ovarian stimulation protocol.0 / 90 / 90 / 9

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedSurrey 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. PMID 19171333

Eligibility

Who could join, as posted.

Sex
Female
Age
from 21 Years up to 42 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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