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

This study has suspended participant recruitment.
(Implantation rate significantly lower in treatment group than Controls.)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00588250
First received: December 22, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  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 Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Randomized Clinical Trial of Novel Implantation Promoting Medium (EmbryoGlue) to Improve IVF Success Rates

Resource links provided by NLM:


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
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.

  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
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, see Learn About Clinical Studies.

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:
No publications provided

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

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

ClinicalTrials.gov processed this record on August 18, 2014