Randomized Trial Comparing EmbryoScope With EmbryoScope+.
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|ClinicalTrials.gov Identifier: NCT03522350|
Recruitment Status : Terminated (Device has been FDA approved.)
First Posted : May 11, 2018
Results First Posted : May 31, 2019
Last Update Posted : May 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Device: EmbryoScope Device: EmbryoScope+||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial Comparing EmbryoScope Time-Lapse System With the New Model EmbryoScope+.|
|Actual Study Start Date :||September 6, 2017|
|Actual Primary Completion Date :||June 4, 2018|
|Actual Study Completion Date :||June 4, 2018|
Active Comparator: EmbryoScope
Standard of care embryo incubator.
Standard of care arm
New experimental embryo incubator.
- Number of Day 3 Embryos [ Time Frame: Day 3 post retrieval ]Comparing number of embryos that fertilized normally and had development at Day 3 based on embryo grade between oocytes assigned to Standard EmbryoScope versus oocytes assigned to EmbryoScope+
- Number of Day 5 Embryos [ Time Frame: Day 5 post retrieval ]Comparing the number pf embryos that developed at Day 5 based on embryo grade between oocytes assigned to Standard EmbryoScope versus oocytes assigned to EmbryoScope+
- Implantation Rate [ Time Frame: 5-6 weeks post retrieval ]Presence of a gestational sac
- Pregnancy Rate [ Time Frame: 2 weeks post retrieval ]Positive Bhcg
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522350
|United States, New York|
|Center for Reproductive Medicine|
|New York, New York, United States, 10065|
|Principal Investigator:||Nikica Zaninovic, PhD||Center for Reproductive Medicine|