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

NCT ID: NCT02948205

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Brief Summary

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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

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Conditions

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Infertility, Female

Keywords

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Infertility, TU-LESS, 3D laparoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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3D group

infertility patient get TU-LESS by 3D Laparoscopy

Group Type EXPERIMENTAL

3D group

Intervention Type PROCEDURE

infertility patient get TU-LESS by 3D Laparoscopy

normal group

infertility patient get normal laparoscopic surgery

Group Type OTHER

normal group

Intervention Type PROCEDURE

infertility patient get normal laparoscopic surgery

Interventions

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3D group

infertility patient get TU-LESS by 3D Laparoscopy

Intervention Type PROCEDURE

normal group

infertility patient get normal laparoscopic surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai First Maternity and Infant Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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ShanghaiFMIH-3D

Identifier Type: -

Identifier Source: org_study_id