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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02948205
Recruitment Status : Not yet recruiting
First Posted : October 28, 2016
Last Update Posted : October 28, 2016
Information provided by (Responsible Party):
Shanghai First Maternity and Infant Hospital

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.

Condition or disease Intervention/treatment Phase
Infertility, Female Procedure: 3D group Procedure: normal group Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Analysis of Trans-umbilical Laparoendoscopic Single-site Surgery by 3D Laparoscopy in the Treatment of Infertility
Study Start Date : December 2016
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 3D group
infertility patient get TU-LESS by 3D Laparoscopy
Procedure: 3D group
infertility patient get TU-LESS by 3D Laparoscopy

normal group
infertility patient get normal laparoscopic surgery
Procedure: normal group
infertility patient get normal laparoscopic surgery

Primary Outcome Measures :
  1. pain score [ Time Frame: in 24 hours after surgery ]
    Visual Analogue Score for the pain feeling of the patient

  2. pregnancy rate [ Time Frame: 6 months after surgery ]

Secondary Outcome Measures :
  1. Operation time [ Time Frame: intraoperative ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Responsible Party: Shanghai First Maternity and Infant Hospital Identifier: NCT02948205     History of Changes
Other Study ID Numbers: ShanghaiFMIH-3D
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Shanghai First Maternity and Infant Hospital:
Infertility, TU-LESS, 3D laparoscopy

Additional relevant MeSH terms:
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female