Commercial Single Step (Vitrolife -G-TL™) Media Compared With Cornell Media

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-04-30

Brief Summary

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This is a randomized, controlled, single-center study in otherwise healthy infertile female subjects undergoing in vitro fertilization (IVF). The subjects recruited for this study will be among those patients who have been diagnosed with infertility and are planning to undergo IVF at the centers where this study is being performed. The patients will have undergone the usual informed consent procedure at the center.

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Detailed Description

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Subjects will undergo ovarian stimulation, oocyte retrieval, IVF, and Intra Cytoplasmic Sperm Injection (ICSI) procedure following the center's usual procedures. The cohort of injected oocytes from each patient will be randomly divided between the one step and sequential medias: CRM (Cornell- Center for Reproductive Medicine) media (C1/C2 or C3) vs G-TL Time Lapse media or G-1/G-2 media. Single step or sequential media are both buffered mediums for culture from oocyte fertilization to blastocyst stage. Sequential media is formulated according to the stages of embryo development and embryos are re-cultured in medias according to their stage of development. Single step (time lapse) media is formulated for continuous culture from D0 to Day 5/6.

Mature oocytes will be randomized via a non-bias computer program into two to four of the study groups: G-TL commercial single step (Vitrolife), Vitrolife's sequential media, Cornell's single step , and Cornell's sequential media. Oocytes will be divided randomly among the various media dependent upon the number of mature oocytes. I.e.: 10 oocytes injected = 2 media groups; 15 oocytes injected = up to 3 media groups; 20 oocytes injected = up to 4 media groups.

"Best grade" embryos will be transferred regardless of media source. If embryos are transferred from multi-source media and if researchers are unable to determine the media source after transfer, the subject will not be included in the outcome data portion of the study- e.g pregnancy outcome.

The Time-Lapse monitoring system will be used as standard clinical practice to observe development and document timing of embryo cleavages and morphology dynamics.

Endpoints will be Day 3 and Day 5/6 embryo development, implantation and pregnancy rate. The study is approximately 2 months, the estimated time it takes a physician to perform one IVF-ART IVF- Assisted Reproductive Technology) treatment cycle. If embryos are frozen, the patient may be in the study until the time they choose to thaw the embryos or up to 1 year if they become pregnant.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CRM sequential media (C1/C2)

CRM sequential media, formulated according to the stages of embryo development, is used to culture the embryos from oocyte fertilization to blastocyst stage.

Group Type ACTIVE_COMPARATOR