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

This study has been suspended.

( Implantation rate significantly lower in treatment group than Controls. )

First Received: December 22, 2007 No Changes Posted

Sponsored by:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00588250

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

MedlinePlus related topics: Infertility

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment
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
Estimated Study Completion Date:	June 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Other: EmbryoGlue G2 culture media from Vitrolife which contains hyaluronic acid
B: No Intervention

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

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mayo Clinic ( Dean E. Morbeck, PhD )
Study ID Numbers:	876-04
Study First Received:	December 22, 2007
Last Updated:	December 22, 2007
ClinicalTrials.gov Identifier:	NCT00588250 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Genital Diseases, Female
Infertility
Hyaluronic Acid
Genital Diseases, Male

Additional relevant MeSH terms:

Genital Diseases, Female
Infertility
Genital Diseases, Male

ClinicalTrials.gov processed this record on May 07, 2009