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

NCT01939626 | Completed

• 1 other identifier: TL-SCM-2013
• Study Type: interventional
• Target: 128
• Locations: 2 countries
• Sites: 4

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.

Conditions

Infertility

Keywords

embryo; culture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• % GQE DAY 3

  Measured 3 days after oocyte pick-up

• Blast. Utilization rate

  Measured 5 and 6 days after oocyte pick-up

• Blast. rate

  Measured 5 and 6 days after oocyte pick-up.

Study Arms (2)

Single-step medium

EXPERIMENTAL

embryos will be cultured in a single-step medium for 5 days with no change

Device: Single-step medium

Control

OTHER

Embryos cultured in two Culture media for 5 Days.

Device: Standard culture medium

Interventions

Single-step medium DEVICE

This medium will allow in vitro culture of human embryos for 5/6 days

Also known as: Single step culture medium

Single-step medium

Standard culture medium DEVICE

This culture system needs media change on day 3 of culture.

Control

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Previous history of cancer
• Day 3 embryo transfer

Sponsors & Collaborators

• Vitrolife: lead

Study Sites (4)

Pacific Fertility Center

San Francisco, California, 94133, United States

Location

Frisco IVF

Frisco, Texas, 75034, United States

Location

Fertilitetscentrum

Gothenburg, 40229, Sweden

Location

Skanes University Hospital

Malmo, 20502, Sweden

Location

Related Publications (1)

• Hardarson T, Bungum M, Conaghan J, Meintjes M, Chantilis SJ, Molnar L, Gunnarsson K, Wikland M. Noninferiority, randomized, controlled trial comparing embryo development using media developed for sequential or undisturbed culture in a time-lapse setup. Fertil Steril. 2015 Dec;104(6):1452-9.e1-4. doi: 10.1016/j.fertnstert.2015.08.037. Epub 2015 Sep 25.

  PMID: 26409153 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Thorir Hardarson, PhD

  Fertilitetscentrum AB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: To minimize the possible bias for the primary outcome, the embryologist performing the morphologic evaluation on day 3 and 5-6 was blinded to the treatments. The physician, the embryologist, and the couple were also blinded to the culture group from which the embryo had been selected for transfer.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study was a two-arm, prospective, randomized, controlled clinical trial performed at four independent IVF clinics. Ovarian stimulation and oocyte collection and fertilization were performed as per each clinic's practice. If \>6 oocytes from the patient were fertilized, the resulting zygotes underwent stratified randomization into the two different media. Allocation was performed in a 1:1 ratio according to a computer-generated randomization list for each couple, which was provided in sealed and numbered envelopes to each clinic. Zygotes randomized into G-1/G-2 underwent a media change from G-1 to G-2 on day 3 and subsequent culture until days 5-6. The zygotes randomized to G-TL were cultured continuously without any media change until days 5-6.

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: September 11, 2013
• Study Start: September 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: January 12, 2021

Record last verified: 2021-01

Locations

US (2); SE (2)