Clinical trial NCT01939626: Comparison of Human Embryo Development Using Sequential and Single Media With Time-lapse Imaging
Official title: Comparison of Human Embryonic Development Using Sequential and Single Media in IVF Monitored by Time-lapse Imaging.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: embryo
culture
Lead sponsor: Vitrolife
Sponsor class: INDUSTRY
First posted: 2013-09-11
Enrollment: 128
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of good quality blastocysts
timeFrame: 5 days of in vitro embryo culture
Secondary outcomes:
measure: % GQE DAY 3
timeFrame: Measured 3 days after oocyte pick-up
measure: Blast. Utilization rate
timeFrame: Measured 5 and 6 days after oocyte pick-up
measure: Blast. rate
timeFrame: Measured 5 and 6 days after oocyte pick-up.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Pacific Fertility Center
state: California
city: Frisco
country: United States
facility: Frisco IVF
state: Texas
city: Goteburg
country: Sweden
facility: Fertilitetscentrum
city: Malmo
country: Sweden
facility: Skanes University Hospital
Study officials:
affiliation: Fertilitetscentrum AB
name: Thorir Hardarson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.