NCT02948205

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

2 years

First QC Date

October 25, 2016

Last Update Submit

October 26, 2016

Conditions

Infertility, Female

Keywords

Infertility, TU-LESS, 3D laparoscopy

Outcome Measures

Primary Outcomes (2)

  • pain score

    Visual Analogue Score for the pain feeling of the patient

    in 24 hours after surgery

  • pregnancy rate

    6 months after surgery

Secondary Outcomes (1)

  • Operation time

    intraoperative

Study Arms (2)

3D group

EXPERIMENTAL

infertility patient get TU-LESS by 3D Laparoscopy

Procedure: 3D group

normal group

OTHER

infertility patient get normal laparoscopic surgery

Procedure: normal group

Interventions

3D groupPROCEDURE

infertility patient get TU-LESS by 3D Laparoscopy

3D group
normal groupPROCEDURE

infertility patient get normal laparoscopic surgery

normal group

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility, FemaleInfertility

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2016

First Posted

October 28, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2018

Last Updated

October 28, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share