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Extending the hCG OPU Interval (DelOPU)

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Delaying oocyte pick up beyond 39 hours post hCG
Sponsored by
The Baruch Padeh Medical Center, Poriya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

20 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Previous 2 oocyte pick up cycles with 20% metaphase II oocytes in the cohort -

Exclusion Criteria:

No previous IVF history

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Delay

    Arm Description

    Delaying oocyte pick up beyond 39 hours post hCG

    Outcomes

    Primary Outcome Measures

    Conception

    Secondary Outcome Measures

    Full Information

    First Posted
    August 14, 2016
    Last Updated
    August 17, 2016
    Sponsor
    The Baruch Padeh Medical Center, Poriya
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02871154
    Brief Title
    Extending the hCG OPU Interval
    Acronym
    DelOPU
    Official Title
    Extending the Time Period Between the Injection of Chorionic Gonadotropin and Oocyte Pick-up as a Solution to Low Rate of Mature Oocyte and Poor Results in Assisted Reproduction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Baruch Padeh Medical Center, Poriya

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Our and others experience suggest that in some cases delaying oocyte pick up (OPU) for more than 39 hours after hCG injection may be of benefit. We plan to apply this to 20 women in whom less than 20% of oocytes were found suitable for intracytoplasmic sperm injection. The delay will be for up to an interval of 47 hours from hCG to OPU.
    Detailed Description
    In IVF one encounters some women in whom a low percentage of oocytes are found in the metaphase II stage upon their retrieval. Following some incidents, in our experience as well as others', where women injected hCG too early but oocytes were still retrieved with high proportion of maturity, we decided to delay OPU intentionally in women who had low percentage oocyte maturity in previous cycles.

    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
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Delay
    Arm Type
    Experimental
    Arm Description
    Delaying oocyte pick up beyond 39 hours post hCG
    Intervention Type
    Other
    Intervention Name(s)
    Delaying oocyte pick up beyond 39 hours post hCG
    Intervention Description
    Unlike the traditional less-than 39 hours interval from hCG injection to oocyte pick up, we will extend the interval up to 47 hours
    Primary Outcome Measure Information:
    Title
    Conception
    Time Frame
    Two years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    38 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Previous 2 oocyte pick up cycles with 20% metaphase II oocytes in the cohort - Exclusion Criteria: No previous IVF history -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Izhar Ben Shlomo, MD
    Phone
    972-52-6124781
    Email
    ibenshlomo@poria.health.gov.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Johenny S Younis, MD
    Phone
    972-50-6265477
    Email
    jyounis@poria.health.gov.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Odeh-L'ya Katz, PhD
    Organizational Affiliation
    Beruch Padeh Med Ctr Research Authority
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Study results

    Learn more about this trial

    Extending the hCG OPU Interval

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