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Does Transfer of Poor-quality Embryos With Good-quality Embryos Improve Pregnancy Outcome in Women Undergoing IVF/ICSI?

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Embryo transfer
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • women undergoing primary IVF/ICSI cycles for tubal factor/unexplained infertility and had blastocyst-stage ET

Exclusion Criteria:

  • cleavage-stage ET.
  • women who had no good-quality embryos to transfer
  • women who had known poor endometrial receptivity

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Good-quality embryo transfer

    good- and poor-quality embryo transfer

    Arm Description

    Women who had only good-quality embryo transfer

    Women who had both good- and poor-quality embryo transfer

    Outcomes

    Primary Outcome Measures

    Ongoing clinical pregnancy rate
    viable intrauterine pregnancy ongoing beyond 12 weeks of gestation

    Secondary Outcome Measures

    Biochemical pregnancy rate
    positive serum hCG
    Clinical pregnancy rate
    sonographic detection of viable intrauterine gestational sac
    Multiple pregnancy rate
    No. of intrauterine gestational sacs
    Ectopic pregnancy rate
    Extrauterine pregnancy

    Full Information

    First Posted
    April 10, 2017
    Last Updated
    April 10, 2017
    Sponsor
    Ain Shams University
    Collaborators
    Dar El Teb Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03113097
    Brief Title
    Does Transfer of Poor-quality Embryos With Good-quality Embryos Improve Pregnancy Outcome in Women Undergoing IVF/ICSI?
    Official Title
    Does Transfer of Poor-quality Embryos With Good-quality Embryos Improve Pregnancy Outcome in Women Undergoing IVF/ICSI?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2014 (Actual)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    March 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University
    Collaborators
    Dar El Teb Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Women planned to undergo blastocyst-stage embryo transfer after IVF/ICSI were randomized into 2 groups: group I: women who had only good-quality embryo transfer. group II: women who had both good-quality and poor-quality embryo transfer. primary outcome was ongoing clinical pregnancy rate

    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
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    627 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Good-quality embryo transfer
    Arm Type
    Active Comparator
    Arm Description
    Women who had only good-quality embryo transfer
    Arm Title
    good- and poor-quality embryo transfer
    Arm Type
    Active Comparator
    Arm Description
    Women who had both good- and poor-quality embryo transfer
    Intervention Type
    Other
    Intervention Name(s)
    Embryo transfer
    Intervention Description
    Transfer of different qualities of embryos at blastocyst stage
    Primary Outcome Measure Information:
    Title
    Ongoing clinical pregnancy rate
    Description
    viable intrauterine pregnancy ongoing beyond 12 weeks of gestation
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Biochemical pregnancy rate
    Description
    positive serum hCG
    Time Frame
    2 weeks after ET
    Title
    Clinical pregnancy rate
    Description
    sonographic detection of viable intrauterine gestational sac
    Time Frame
    4 weeks after ET
    Title
    Multiple pregnancy rate
    Description
    No. of intrauterine gestational sacs
    Time Frame
    4-6 weeks after ET
    Title
    Ectopic pregnancy rate
    Description
    Extrauterine pregnancy
    Time Frame
    6 weeks after ET

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: women undergoing primary IVF/ICSI cycles for tubal factor/unexplained infertility and had blastocyst-stage ET Exclusion Criteria: cleavage-stage ET. women who had no good-quality embryos to transfer women who had known poor endometrial receptivity
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohammed Faris, MD
    Organizational Affiliation
    Dar El Teb IVF and Infertility Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Does Transfer of Poor-quality Embryos With Good-quality Embryos Improve Pregnancy Outcome in Women Undergoing IVF/ICSI?

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