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Endometrial Follicular Fluid Flushing and IVF Outcome

Primary Purpose

Clinical Pregnancy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
follicular fluid flushing
Sponsored by
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clinical Pregnancy

Eligibility Criteria

20 Years - 39 Years (Adult)FemaleAccepts Healthy Volunteers

inclusion criteria:age between 20-39 years, basal FSH level < 10 mIU/ml, body mass index<35 kg/m2 and E2 levels in human chorionic gonadotropin (hCG) day between 1000-4000 pg/ml. -

Exclusion Criteria:previously diagnosed endometriosis, uterine leiomyomas, hydrosalpinx, endocrinological disorders; previous history of implantation failure in IVF/ICSI cycles and severe male factor infertility.

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    İntracavitary fluid flushing

    Control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Clinical pregnancy
    intrauterine pregnancy with metal cardiac activity

    Secondary Outcome Measures

    Full Information

    First Posted
    March 12, 2020
    Last Updated
    July 18, 2020
    Sponsor
    Zeynep Kamil Maternity and Pediatric Research and Training Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04479059
    Brief Title
    Endometrial Follicular Fluid Flushing and IVF Outcome
    Official Title
    Endometrial Follicular Fluid Flushing and IVF Outcome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2016 (Actual)
    Primary Completion Date
    May 30, 2017 (Actual)
    Study Completion Date
    May 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zeynep Kamil Maternity and Pediatric Research and Training Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    Objective: In this study, our aim will be investigating the pregnancy results in unexplained infertile women undergoing ICSI, by flushing the endometrial cavity with folliculer fluid, that we maintain mature follicules inside them in oocyte retrieval day. Study Design: 100 subfertile women who applied to Zeynep Kamil Hospital, In Vitro Fertilization Center between October 2016 to May 2017 will be randomized with computer generated programme. The patients will be divided into two groups; follicular fluid group (n=50) and control group (n=50). The inclusion criterias are: age between 20-39 years, basal FSH level < 10 mIU/ml, body mass index<35 kg/m2 and E2 levels in human chorionic gonadotropin (hCG) day between 1000-4000 pg/ml. Patients meets these criteria will be included to the study programme. The exclusion criteria are determined as below: previously diagnosed endometriosis, uterine leiomyomas, hydrosalpinx, endocrinological disorders; previous history of implantation failure in IVF/ICSI cycles and severe male factor infertility.
    Detailed Description
    Objective: In this study, our aim will be investigating the pregnancy results in unexplained infertile women undergoing ICSI, by flushing the endometrial cavity with folliculer fluid, that we maintain mature follicules inside them in oocyte retrieval day. Study Design: 100 subfertile women who applied to Zeynep Kamil Hospital, In Vitro Fertilization Center between October 2016 to May 2017 will be randomized with computer generated programme. The patients will be divided into two groups; follicular fluid group (n=50) and control group (n=50). The inclusion criterias are: age between 20-39 years, basal FSH level < 10 mIU/ml, body mass index<35 kg/m2 and E2 levels in human chorionic gonadotropin (hCG) day between 1000-4000 pg/ml. Patients meets these criteria will be included to the study programme. The exclusion criteria are determined as below: previously diagnosed endometriosis, uterine leiomyomas, hydrosalpinx, endocrinological disorders; previous history of implantation failure in IVF/ICSI cycles and severe male factor infertility.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    İntracavitary fluid flushing
    Arm Type
    Experimental
    Arm Title
    Control group
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    follicular fluid flushing
    Intervention Description
    Follicular fluid obtained during OPU will be used for endometrial cavity flushing.
    Primary Outcome Measure Information:
    Title
    Clinical pregnancy
    Description
    intrauterine pregnancy with metal cardiac activity
    Time Frame
    during last 24 months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    infertile women
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    39 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    inclusion criteria:age between 20-39 years, basal FSH level < 10 mIU/ml, body mass index<35 kg/m2 and E2 levels in human chorionic gonadotropin (hCG) day between 1000-4000 pg/ml. - Exclusion Criteria:previously diagnosed endometriosis, uterine leiomyomas, hydrosalpinx, endocrinological disorders; previous history of implantation failure in IVF/ICSI cycles and severe male factor infertility. -

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Endometrial Follicular Fluid Flushing and IVF Outcome

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