Embryoscope and Reproductive Outcome

July 24, 2017 updated by: Ahmed Maged

Does Embryoscope Improve Reproductive Outcome in ICSI Patients

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

Study Overview

Status

Completed

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

770

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

770 women undergoing ICSI cycles

Description

Inclusion Criteria:

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

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical pregnancy rate
Time Frame: 14 days after embryo transfer
transvaginal ultrasound done to assess the gestational sac
14 days after embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

May 4, 2016

First Submitted That Met QC Criteria

May 4, 2016

First Posted (Estimate)

May 6, 2016

Study Record Updates

Last Update Posted (Actual)

July 25, 2017

Last Update Submitted That Met QC Criteria

July 24, 2017

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 146

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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