NCT02077608

Brief Summary

Prospective randomized double blind comparison of hyaluronan enriched embryotransfer media and conventional embryotransfer media in human IVF treatments. Embryos selected for transfer are incubated in a culture media containing high concentration of hyaluronan or low concentration of hyaluronan. Primary outcome: implantation and pregnancy rates

Trial Health

87
On Track

Trial Health Score

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

Enrollment
580

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
Last Updated

March 4, 2014

Status Verified

March 1, 2014

Enrollment Period

2.6 years

First QC Date

February 28, 2014

Last Update Submit

March 3, 2014

Conditions

Infertility

Keywords

In vitro fertilizationEmbryotransferHyaluronanPregnancy rateImplantation rate

Outcome Measures

Primary Outcomes (2)

  • Clinical pregnancy rate

    Number of clinical pregnancies (gestational sacs visible by ultrasound examination) divided by the number of embryotransfers

    5 weeks after embryo transfer

  • Implantation rate

    Number of embryos implanted (No. of gestational sacs) divided by the number of embryos implanted

    5 weeks after embryotransfer

Secondary Outcomes (2)

  • Multiple pregnancy rate

    5 weeks after embryotransfer

  • Delivery rate

    40 weeks after embryo transfer

Study Arms (2)

Hyaluronan enriched transfer media

Embryos are incubated at least 10 minutes in hyaluronan enriched embryo transfer media before transfer

Control group

Embryos are incubated in embryo transfer media containing low concentration of hyaluronan for at least 10 minutes before transfer

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients entering in vitro fertilization and embryo transfer treatment

You may qualify if:

  • Infertile patients
  • entering in vitro fertilization treatment
  • at least 1 embryo transferred

You may not qualify if:

  • IVF treatment with donated oocytes
  • No embryo available for transfer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Semmelweis University First Department of Obstetrics and Gynecology

Budapest, 1088, Hungary

Location

Related Publications (1)

  • Bontekoe S, Heineman MJ, Johnson N, Blake D. Adherence compounds in embryo transfer media for assisted reproductive technologies. Cochrane Database Syst Rev. 2014 Feb 25;2014(2):CD007421. doi: 10.1002/14651858.CD007421.pub3.

    PMID: 24567053RESULT

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Peter Fancsovits, Ph.D.

    Semmelweis University First Department of Obstetrics and Gynecology

    STUDY CHAIR

  • Janos Urbancsek, MD, Ph.D.

    Semmelweis University First Department of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

  • Adam Lehner, MSc

    Semmelweis University First Department of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Clincial Embryologist

Study Record Dates

First Submitted

February 28, 2014

First Posted

March 4, 2014

Study Start

January 1, 2010

Primary Completion

August 1, 2012

Study Completion

December 1, 2013

Last Updated

March 4, 2014

Record last verified: 2014-03

Locations

HU(1)