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

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Device: Single-step medium; Device: Standard culture medium

• Registration Number: NCT01939626
• Lead Sponsor: Vitrolife

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-08-28
• Study Start: 2013-09
• Study First Submitted QC: 2013-09-06
• Study First Posted: 2013-09-11
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-08
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-step medium	Single-step medium	embryos will be cultured in a single-step medium for 5 days with no change
Control	Standard culture medium	Embryos cultured in two Culture media for 5 Days.

Primary Outcome Measures

Name	Time	Method
Percentage of good quality blastocysts	5 days of in vitro embryo culture	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.

Secondary Outcome Measures

Name	Time	Method
% GQE DAY 3	Measured 3 days after oocyte pick-up	Percentage of good quality embryos on day 3 of development
Blast. rate	Measured 5 and 6 days after oocyte pick-up.	Number of embryos reaching the blastocyts stage on either day 5 or day 6.
Blast. Utilization rate	Measured 5 and 6 days after oocyte pick-up	Number of blastocyst that are cryopreserved or transfered on either day 5 or 6 of embryo development.

Trial Locations

Locations (4)

Frisco IVF; 🇺🇸 Frisco, Texas, United States

Pacific Fertility Center; 🇺🇸 San Francisco, California, United States

Fertilitetscentrum; 🇸🇪 Goteburg, Sweden

Skanes University Hospital; 🇸🇪 Malmo, Sweden