NCT02764255

Brief Summary

cases with embyos cultured in the standard incubator and evaluated only by morphology are compared to cases with embryos continuously monitored by the embryoscope followed by embryo selection based on a multivariable model

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
770

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 25, 2017

Status Verified

May 1, 2016

Enrollment Period

1.2 years

First QC Date

May 4, 2016

Last Update Submit

July 24, 2017

Conditions

Invitro Fertilization

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate

    transvaginal ultrasound done to assess the gestational sac

    14 days after embryo transfer

Study Arms (2)

embryoscope group

cases with embryos continuously monitored by the embryoscope followed by embryo selection based on a multivariable model

control group

cases with embyos cultured in the standard incubator and evaluated only by morphology

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

770 women undergoing ICSI cycles

You may qualify if:

  • Patient age:25-40 years old
  • BMI:18-30
  • patients with first or second ICSI trial

You may not qualify if:

  • AMH \<1
  • severe male factor(total motile sperm \<1 million)
  • frozen embryo transfer cycles
  • patients with endocrinopathies or thrombophilia
  • patients on medical treatment which may interfere with results
  • hydrosalpinx

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Ahmed Maged, MD

    Kasr Alainy medical school

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 4, 2016

First Posted

May 6, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 25, 2017

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share