Comparison of Human Embryo Development Using Sequential and Single Media With Time-lapse Imaging

Infertility Clinical Trial

Official title:

Comparison of Human Embryonic Development Using Sequential and Single Media in IVF Monitored by Time-lapse Imaging.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939626
• Other study ID #: TL-SCM-2013
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: February 2014

Study information

• Verified date: January 2021
• Source: Vitrolife
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare human embryo in vitro development in sequential and single-step culture medium using time-lapse imaging.

Description:

Objective: To study whether a culture medium that allows undisturbed culture supports human embryo development to the blastocyst stage equivalently to a well-established sequential media. Design: Randomized, double-blinded sibling trial. Setting: Independent in vitro fertilization (IVF) clinics. Patient(s): One hundred twenty-eight patients, with 1,356 zygotes randomized into two study arms. Intervention(s): Embryos from each patient were randomly allocated into two study arms to compare embryo development on a time-lapse system using a single-step medium or sequential media.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

Inclusion Criteria:

• 6 or more normal embryos following egg retrieval and fertilization.
• Female patients aged 21-40 years or 21-55 years who are using an egg donor.
• Patients using fresh or frozen ejaculated sperm

Exclusion Criteria:

• Previous history of cancer
• Day 3 embryo transfer

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• Single-step medium
This medium will allow in vitro culture of human embryos for 5/6 days
• Standard culture medium
This culture system needs media change on day 3 of culture.

Locations

Country	Name	City	State
Sweden	Fertilitetscentrum	Goteburg
Sweden	Skanes University Hospital	Malmo
United States	Frisco IVF	Frisco	Texas
United States	Pacific Fertility Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Vitrolife

Countries where clinical trial is conducted

United States,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of good quality blastocysts	A cohort of human embryos will be divided into two different media. The ability of the media to support human embryo development will be determined using the standard assessment of the percentage of embryos that achieve a defined embryo grade.	5 days of in vitro embryo culture
Secondary	% GQE DAY 3	Percentage of good quality embryos on day 3 of development	Measured 3 days after oocyte pick-up
Secondary	Blast. Utilization rate	Number of blastocyst that are cryopreserved or transfered on either day 5 or 6 of embryo development.	Measured 5 and 6 days after oocyte pick-up
Secondary	Blast. rate	Number of embryos reaching the blastocyts stage on either day 5 or day 6.	Measured 5 and 6 days after oocyte pick-up.