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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Device: Single-step medium
* Device: Standard culture medium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-step medium<br>embryos will be cultured in a single-step medium for 5 days with no change | Device: Single-step medium<br>* This medium will allow in vitro culture of human embryos for 5/6 days<br>* Other names: Single step culture medium;|
| Other: Control<br>Embryos cultured in two Culture media for 5 Days. | Device: Standard culture medium<br>* This culture system needs media change on day 3 of culture.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % GQE DAY 3 | Percentage of good quality embryos on day 3 of development | Measured 3 days after oocyte pick-up | 
| 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 | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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embryo, culture