Commercial Single Step (Vitrolife -G-TL™) Media Compared With Cornell Media
| Status: | Recruiting |
|---|---|
| Conditions: | Infertility |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 4/21/2016 |
| Start Date: | July 2015 |
| End Date: | December 2017 |
Commercial Single Step (Vitrolife -G-TL™) Media Compared With Cornell Media: A Randomized Controlled Trial by Time-Lapse System- Single Step vs Sequential Media
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.
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.
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.
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.
Inclusion Criteria:
- 40 years of age or younger (maternal) 65 years of age or younger (paternal)
- Patient must have 10 or greater than 10 mature oocytes, ICSI only
- Fresh or frozen (including donor) sperm can be used. Fresh oocytes only (including
donor)
- Frozen embryos from this study can be included in the outcome portion of this study.
- Single or double Blastocyst transfer only
Exclusion Criteria:
- Patients having PGS (Pre-implantation Genetic Screening)
- 3 or more previous failed cycles
- Sperm obtained by testicular biopsy
- Previous enrollment in the study
- Non blastocyst transfer
- Co-culture patients
- Outcome data portion exclusion only:
Multi-source media transfers if researchers are unable to determine the media source after
transfer.
We found this trial at
1
site
New York, New York 10021
Principal Investigator: Gianpiero Palermo, MD, PhD
Phone: 646-962-3276
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