- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02764255
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
Conditions
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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