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Embryoscope and Reproductive Outcome

Sponsor
Ahmed Maged (Other)
Overall Status
Completed
CT.gov ID
NCT02764255
Collaborator
(none)
770
Enrollment
14
Actual Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    770 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Does Embryoscope Improve Reproductive Outcome in ICSI Patients
    Actual Study Start Date :
    May 1, 2016
    Actual Primary Completion Date :
    Jul 1, 2017
    Actual Study Completion Date :
    Jul 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. clinical pregnancy rate [14 days after embryo transfer]

      transvaginal ultrasound done to assess the gestational sac

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 39 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ahmed Maged

    Investigators

    • Principal Investigator: Ahmed Maged, MD, Kasr Alainy medical school

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Maged, Assistant professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT02764255
    Other Study ID Numbers:
    • 146
    First Posted:
    May 6, 2016
    Last Update Posted:
    Jul 25, 2017
    Last Verified:
    May 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Jul 25, 2017