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Analysis of TU-LESS by 3D Laparoscopy in the Treatment of Infertility

Primary Purpose

Infertility, Female

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
3D group
normal group
Sponsored by
Shanghai First Maternity and Infant Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female focused on measuring Infertility, TU-LESS, 3D laparoscopy

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients are younger than 36 and older than 24.
  2. Clearly diagnosed with female Infertility.
  3. Infertility within 1 to 10 years.
  4. informed consent form signed

Exclusion Criteria:

  1. Over the age of 35.
  2. Indefinite diagnosis.
  3. With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs).
  4. abdominal surgery history
  5. Unwilling to comply with the research plan.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    3D group

    normal group

    Arm Description

    infertility patient get TU-LESS by 3D Laparoscopy

    infertility patient get normal laparoscopic surgery

    Outcomes

    Primary Outcome Measures

    pain score
    Visual Analogue Score for the pain feeling of the patient
    pregnancy rate

    Secondary Outcome Measures

    Operation time

    Full Information

    First Posted
    October 25, 2016
    Last Updated
    October 26, 2016
    Sponsor
    Shanghai First Maternity and Infant Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02948205
    Brief Title
    Analysis of TU-LESS by 3D Laparoscopy in the Treatment of Infertility
    Official Title
    Analysis of Trans-umbilical Laparoendoscopic Single-site Surgery by 3D Laparoscopy in the Treatment of Infertility
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai First Maternity and Infant Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study intends to carry out a prospective, randomized controlled trial to compare the trans-umbilical laparoendoscopic single-site surgery by 3D laparoscopy with normal laparoendoscopic surgery in the treatment of infertility patient, so as to further clarify the safety and curative effect of TU-LESS by 3D laparoscopy and provide evidence-based basis for its application in infertility population.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility, Female
    Keywords
    Infertility, TU-LESS, 3D laparoscopy

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    3D group
    Arm Type
    Experimental
    Arm Description
    infertility patient get TU-LESS by 3D Laparoscopy
    Arm Title
    normal group
    Arm Type
    Other
    Arm Description
    infertility patient get normal laparoscopic surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    3D group
    Intervention Description
    infertility patient get TU-LESS by 3D Laparoscopy
    Intervention Type
    Procedure
    Intervention Name(s)
    normal group
    Intervention Description
    infertility patient get normal laparoscopic surgery
    Primary Outcome Measure Information:
    Title
    pain score
    Description
    Visual Analogue Score for the pain feeling of the patient
    Time Frame
    in 24 hours after surgery
    Title
    pregnancy rate
    Time Frame
    6 months after surgery
    Secondary Outcome Measure Information:
    Title
    Operation time
    Time Frame
    intraoperative

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients are younger than 36 and older than 24. Clearly diagnosed with female Infertility. Infertility within 1 to 10 years. informed consent form signed Exclusion Criteria: Over the age of 35. Indefinite diagnosis. With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs). abdominal surgery history Unwilling to comply with the research plan.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Analysis of TU-LESS by 3D Laparoscopy in the Treatment of Infertility

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