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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02948205
• Other study ID #: ShanghaiFMIH-3D
• Status: Not yet recruiting
• Phase: N/A
• First received: October 25, 2016
• Last updated: October 26, 2016
• Start date: December 2016

Study information

• Verified date: October 2016
• Source: Shanghai First Maternity and Infant Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Procedure:
• 3D group
infertility patient get TU-LESS by 3D Laparoscopy
• normal group
infertility patient get normal laparoscopic surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai First Maternity and Infant Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score	Visual Analogue Score for the pain feeling of the patient	in 24 hours after surgery	No
Primary	pregnancy rate		6 months after surgery	No
Secondary	Operation time		intraoperative	No