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

Shanghai First Maternity and Infant Hospital500 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

500

Conditions

Infertility, Female

Interventions

3D groupPROCEDURE

infertility patient get TU-LESS by 3D Laparoscopy

normal groupPROCEDURE

infertility patient get normal laparoscopic surgery

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 35 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

pain score

Visual Analogue Score for the pain feeling of the patient

Time frame: in 24 hours after surgery

pregnancy rate

Time frame: 6 months after surgery

Secondary Outcomes

Operation time

Time frame: intraoperative

Data from ClinicalTrials.gov

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