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

Not Applicable

• Conditions: Infertility, Female

• Registration Number: NCT02948205
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-26
• Last Update Submitted: 2016-10-26
• Study First Posted: 2016-10-28
• Last Update Posted: 2016-10-28
• Study Start: 2016-12
• Primary Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
pain score	in 24 hours after surgery	Visual Analogue Score for the pain feeling of the patient
pregnancy rate	6 months after surgery

Secondary Outcome Measures

Name	Time	Method
Operation time	intraoperative