Back to resultsClinical Trial of Novel Implantation Promoting Medium (EmbryoGlue) to Improve IVF Success Rates
Primary Purpose
Embryo Implantation, Infertility
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EmbryoGlue
Sponsored by
About this trial
This is an interventional treatment trial for Embryo Implantation
Eligibility 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).
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Pregnancy Rate
Secondary Outcome Measures
Implantation rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00588250
Brief Title
Clinical Trial of Novel Implantation Promoting Medium (EmbryoGlue) to Improve IVF Success Rates
Official Title
Prospective Randomized Clinical Trial of Novel Implantation Promoting Medium (EmbryoGlue) to Improve IVF Success Rates
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Implantation rate significantly lower in treatment group than Controls.
Study Start Date
May 2003 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Embryo Implantation, Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
EmbryoGlue
Intervention Description
G2 culture media from Vitrolife which contains hyaluronic acid
Primary Outcome Measure Information:
Title
Pregnancy Rate
Time Frame
one month
Secondary Outcome Measure Information:
Title
Implantation rate
Time Frame
two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dean E Morbeck, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Clinical Trial of Novel Implantation Promoting Medium (EmbryoGlue) to Improve IVF Success Rates
We'll reach out to this number within 24 hrs