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Clinical Trials/NCT02948205
NCT02948205
Unknown
Not Applicable

Analysis of Trans-umbilical Laparoendoscopic Single-site Surgery by 3D Laparoscopy in the Treatment of Infertility

Shanghai First Maternity and Infant Hospital0 sites500 target enrollmentDecember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility, Female
Sponsor
Shanghai First Maternity and Infant Hospital
Enrollment
500
Primary Endpoint
pain score
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
December 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Over the age of
  • 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.

Outcomes

Primary Outcomes

pain score

Time Frame: in 24 hours after surgery

Visual Analogue Score for the pain feeling of the patient

pregnancy rate

Time Frame: 6 months after surgery

Secondary Outcomes

  • Operation time(intraoperative)

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