NCT00588250

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 8, 2008

Completed
Last Updated

May 8, 2023

Status Verified

May 1, 2023

Enrollment Period

2.1 years

First QC Date

December 22, 2007

Last Update Submit

May 5, 2023

Conditions

Embryo ImplantationInfertility

Outcome Measures

Primary Outcomes (1)

  • Pregnancy Rate

    one month

Secondary Outcomes (1)

  • Implantation rate

    two months

Study Arms (2)

A

EXPERIMENTAL
Other: EmbryoGlue

B

NO INTERVENTION

Interventions

EmbryoGlueOTHER

G2 culture media from Vitrolife which contains hyaluronic acid

A

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Dean E Morbeck, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2007

First Posted

January 8, 2008

Study Start

May 1, 2003

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

May 8, 2023

Record last verified: 2023-05

Locations

US(1)