Clinical trial NCT03522350: Randomized Trial Comparing EmbryoScope With EmbryoScope+.
Official title: Randomized Controlled Trial Comparing EmbryoScope Time-Lapse System With the New Model EmbryoScope+.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Keywords: Infertility
Embryo develpoment
IVF
ICSI
EmbryoScope
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Vitrolife
First posted: 2018-05-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the current EmbryoScope Time-Lapse System being used in IVF which has become standard of care to the new model EmbryoScope to demonstrate that the EmbryoScope+ is as safe and reliable as the EmbryoScope.

Detailed description: 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 center where this study is being performed. The subjects 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. At the time of retrieval, participant's oocytes will be randomly assigned to both groups for comparison: Standard EmbryoScope Time-Lapse system versus EmbryoScope+. The best quality embryos are selected for embryo transfer and the pregnancy outcome is evaluated.

"Best grade" embryos will be transferred regardless of EmbryoScope use. The standard EmbryoScope as well as the EmbryoScope+ monitor system as assigned during the randomization process will be used to observe the embryo development and document timing of embryo cleavages and morphology dynamics. Subjects will not be provided with the time- lapse images.

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 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.

Eligibility criteria: Inclusion Criteria:

* 40 years of age or younger (maternal)
* 65 years of age or younger (paternal)
* 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:

* 3 or more previous failed cycles
* Sperm obtained by testicular biopsy
* Co-culture patients

Primary outcomes:
measure: Number of Day 3 Embryos
timeFrame: Day 3 post retrieval
measure: Number of Day 5 Embryos
timeFrame: Day 5 post retrieval
Secondary outcomes:
measure: Implantation Rate
timeFrame: 5-6 weeks post retrieval
measure: Pregnancy Rate
timeFrame: 2 weeks post retrieval
Other outcomes:
Locations:
city: New York
country: United States
facility: Center for Reproductive Medicine
state: New York
Study officials:
affiliation: Center for Reproductive Medicine
name: Nikica Zaninovic, PhD
role: PRINCIPAL_INVESTIGATOR
References: