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.)
Information provided by:
Mayo Clinic Identifier:
First received: December 22, 2007
Last updated: April 6, 2015
Last verified: April 2015

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
Other: EmbryoGlue

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Implantation rate [ Time Frame: two months ] [ Designated as safety issue: No ]

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
Other Name: EmbryoGlue
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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00588250

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

Additional Information:
No publications provided

Responsible Party: Dean E. Morbeck, PhD, Mayo Clinic Identifier: NCT00588250     History of Changes
Other Study ID Numbers: 876-04
Study First Received: December 22, 2007
Last Updated: April 6, 2015
Health Authority: United States: Food and Drug Administration processed this record on October 02, 2015