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Clinical Trial of Novel Implantation Promoting Medium (EmbryoGlue) to Improve IVF Success Rates

This study has been terminated.
(Implantation rate significantly lower in treatment group than Controls.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00588250
First Posted: January 8, 2008
Last Update Posted: April 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mayo Clinic
  Purpose
Hypothesis: a special solution for improving human embryo implantation, when added to the solution during embryo transfer, will improve implantation rates in embryo transfers using previously frozen embryos.

Condition Intervention
Embryo Implantation Infertility Other: EmbryoGlue

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Randomized Clinical Trial of Novel Implantation Promoting Medium (EmbryoGlue) to Improve IVF Success Rates

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Pregnancy Rate [ Time Frame: one month ]

Secondary Outcome Measures:
  • Implantation rate [ Time Frame: two months ]

Enrollment: 150
Study Start Date: May 2003
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Other: EmbryoGlue
G2 culture media from Vitrolife which contains hyaluronic acid
No Intervention: B

Detailed Description:
EmbryoGlue (TM) is added to embryo transfer solutions immediately prior to the transfer of frozen-thawed human embryos before placement of embryos into the patient uterus.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Frozen embryo transfer patients, men over the age of 18 and women between the ages of 18 and 42 completed years (if using their own eggs and with embryos frozen before 39 completed years) or 18 to 50 completed years if using donated eggs.

Exclusion Criteria:

  • Prior participation in this study, blastocyst transfers, single embryo transfer for medical reasons, prior embryo transfer with large amount of blood on the outside of the catheter, > or = 3 consecutive failed embryo transfers at Mayo Clinic (fresh or frozen-thawed cycles).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00588250


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Dean E Morbeck, PhD Mayo Clinic
  More Information

Additional Information:
Responsible Party: Dean E. Morbeck, PhD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00588250     History of Changes
Other Study ID Numbers: 876-04
First Submitted: December 22, 2007
First Posted: January 8, 2008
Last Update Posted: April 8, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female