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Early Embryo Cleavage And Multiple Pregnancies After ICSI

Primary Purpose

Infertility

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
transfer early cleavage embryos
transfer non early cleavage embryo
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Infertility

Eligibility Criteria

undefined - 35 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI >25 - 30 kg/m2
  • Have two ovaries
  • Regular cycles
  • first ICSI cycle
  • Long midluteal GnRH protocol.

Exclusion Criteria:

  • uterine factor as a cause of female factor infertility
  • pelvic masses or diseases (e.g: endometriosis, fibroids, hydrosalpnix, ...)
  • history of medical disorders (e.g: hypertension, D.M, thyroid dysfunction, liver diseases, renal diseases,...)
  • azoospermia as a cause of male factor infertility

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    transfer early cleavage embryos (EC)

    transfer non early cleavage embryo (NEC)

    Arm Description

    transfer early cleavage embryos

    transfer non early cleavage embryos

    Outcomes

    Primary Outcome Measures

    clinical pregnancy

    Secondary Outcome Measures

    multiple pregnancy

    Full Information

    First Posted
    October 9, 2014
    Last Updated
    October 9, 2014
    Sponsor
    Al-Azhar University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02265055
    Brief Title
    Early Embryo Cleavage And Multiple Pregnancies After ICSI
    Official Title
    Early Embryo Cleavage And Multiple Pregnancies After ICSI
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2010 (undefined)
    Primary Completion Date
    September 2012 (Actual)
    Study Completion Date
    December 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Al-Azhar University

    4. Oversight

    5. Study Description

    Brief Summary
    To observe whether Number of early cleavage embryos can be a predictor for multiple pregnancies after ICSI.
    Detailed Description
    A total of 193 infertile couples, attending the ART unit, International Islamic Center for Population Studies and Research (IICPSR), -Al- Azhar University in the period from December 2010 to September 2012, were included in this study. The controlled ovarian hyperstimulation protocol was performed according to a long GnRH agonist protocol starting in the midluteal phase (day 21) of the preceding cycle. Embryos were assessed at 25 - 27 hr after ICSI for early cleavage. Embryos which reached the two cell stage at this interval were classified as Early Cleavage (EC) embryos, and the remaining as Non Early Cleavage (NEC) embryos. Embryos were assessed again at 64 - 68 hours post-ICSI for day-three embryo morphology. Day 3 embryo transfer was done. The best two or three embryos, according to day 3 embryo morphology were transferred. The patients were subdivided into two subgroups; one will transfer early cleavage embryos (EC) and the other will transfer non early cleavage embryo (NEC).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    193 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    transfer early cleavage embryos (EC)
    Arm Type
    Active Comparator
    Arm Description
    transfer early cleavage embryos
    Arm Title
    transfer non early cleavage embryo (NEC)
    Arm Type
    Active Comparator
    Arm Description
    transfer non early cleavage embryos
    Intervention Type
    Procedure
    Intervention Name(s)
    transfer early cleavage embryos
    Intervention Description
    transfer early cleavage embryos
    Intervention Type
    Procedure
    Intervention Name(s)
    transfer non early cleavage embryo
    Primary Outcome Measure Information:
    Title
    clinical pregnancy
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    multiple pregnancy
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    Female
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: BMI >25 - 30 kg/m2 Have two ovaries Regular cycles first ICSI cycle Long midluteal GnRH protocol. Exclusion Criteria: uterine factor as a cause of female factor infertility pelvic masses or diseases (e.g: endometriosis, fibroids, hydrosalpnix, ...) history of medical disorders (e.g: hypertension, D.M, thyroid dysfunction, liver diseases, renal diseases,...) azoospermia as a cause of male factor infertility
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    mahmoud edessy, prof
    Organizational Affiliation
    ALAZHAR UNIVERSITY
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    abd elnasr m ali, prof
    Organizational Affiliation
    ALAZHAR UNIVERSITY
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    ahmed fata, prof
    Organizational Affiliation
    ALAZHAR UNIVERSITY
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    wael hamed, dr
    Organizational Affiliation
    ALAZHAR UNIVERSITY
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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