Randomized Trial Comparing EmbryoScope With EmbryoScope+.

Infertility Clinical Trial

Official title:

Randomized Controlled Trial Comparing EmbryoScope Time-Lapse System With the New Model EmbryoScope+.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03522350
• Other study ID #: 1612017837
• Status: Terminated
• Phase: N/A
• Start date: September 6, 2017
• Est. completion date: June 4, 2018

Study information

• Verified date: May 2019
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: June 4, 2018
• Est. primary completion date: June 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• EmbryoScope
Standard of care arm
• EmbryoScope+
Experimental arm

Locations

Country	Name	City	State
United States	Center for Reproductive Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Vitrolife

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Day 3 Embryos	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+	Day 3 post retrieval
Primary	Number of Day 5 Embryos	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+	Day 5 post retrieval
Secondary	Implantation Rate	Presence of a gestational sac	5-6 weeks post retrieval
Secondary	Pregnancy Rate	Positive Bhcg	2 weeks post retrieval