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OpenTrials
Completed

NCT Number: NCT00621179

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

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

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

21 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Colorado Center for Reproductive Medicine

Lone Tree, Colorado, 80124, United States

About this study

See summary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Leuprolide acetate in depot suspension

Drug

Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3

Other names: Depot Lupron

No intervention

Other

Primary outcomes

  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.

    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.

Sponsors and collaborators

Lead sponsor

Colorado Center for Reproductive Medicine

Other

Registry information

Official study title

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

Acronym: IntegrinIVF

Important dates

Study start
2003
Primary completion
2009
Study completion
2010
First posted
Feb 22, 2008
Registry last updated
Aug 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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