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

Shanghai First Maternity and Infant Hospital

Status: Unknown

Conditions: Infertility, Female

Treatments: Procedure: normal group; Procedure: 3D group

Study type: Interventional

Funder types: Other

Identifiers

NCT02948205

ShanghaiFMIH-3D

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 25 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

3D group

Experimental group

Description:

infertility patient get TU-LESS by 3D Laparoscopy

Treatment:

Procedure: 3D group

normal group

Other group

Description:

infertility patient get normal laparoscopic surgery

Treatment:

Procedure: normal group