Hyaluronan in Embryo Transfer Media

Infertility Clinical Trial

Official title:

Effect of Hyaluronan Enriched Embryo Transfer Media on IVF Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02077608
• Other study ID #: SemmelweisU-002
• Status: Completed
• Phase: N/A
• First received: February 28, 2014
• Last updated: March 3, 2014
• Start date: January 2010
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Institutional Ethics Committee
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 580
• Est. completion date: December 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

Inclusion Criteria:

• Infertile patients

• entering in vitro fertilization treatment

• at least 1 embryo transferred

Exclusion Criteria:

• IVF treatment with donated oocytes

• No embryo available for transfer

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
Hungary	Semmelweis University First Department of Obstetrics and Gynecology	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Peter Fancsovits, Ph.D.

Country where clinical trial is conducted

Hungary, 

References & 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;2:CD007421. doi: 10.1002/14651858.CD007421.pub3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Number of clinical pregnancies (gestational sacs visible by ultrasound examination) divided by the number of embryotransfers	5 weeks after embryo transfer	No
Primary	Implantation rate	Number of embryos implanted (No. of gestational sacs) divided by the number of embryos implanted	5 weeks after embryotransfer	No
Secondary	Multiple pregnancy rate	Number of multiple pregnancies divided by the number of embryotransfers	5 weeks after embryotransfer	No
Secondary	Delivery rate	Number of delivery divided by the number of embryo transfers	40 weeks after embryo transfer	No