Status unknownNCT02948205Updated Oct 28, 2016

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

An interventional study of 3D group and normal group in Infertility, Female, sponsored by Shanghai First Maternity and Infant Hospital. Status unknown. Open to female participants aged 25 Years to 35 Years. Per ClinicalTrials.gov, last updated 2016-10-28.

Sponsored by Shanghai First Maternity and Infant Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 500
Allocation: Randomized
Ages: 25 Years to 35 Years
Sex: Female

Study 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.

Conditions studied

Infertility, Female

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Keywords

Infertility, TU-LESS, 3D laparoscopy

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 500 is above the median of 120 across 1,698 interventional studies indexed under Infertility.

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Lead sponsor

Shanghai First Maternity and Infant Hospital is the lead sponsor of 45 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 25 Years to 35 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

Patients are younger than 36 and older than 24.
Clearly diagnosed with female Infertility.
Infertility within 1 to 10 years.
informed consent form signed

Exclusion criteria

Exclusion Criteria:

Over the age of 35.
Indefinite diagnosis.
With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs).
abdominal surgery history
Unwilling to comply with the research plan.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 500 participants (estimated)

Study arms

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

Interventions

Procedure3D group
infertility patient get TU-LESS by 3D Laparoscopy
Procedurenormal group
infertility patient get normal laparoscopic surgery

What researchers measure

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

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02948205
Lead sponsor: Shanghai First Maternity and Infant Hospital
Responsible party: Sponsor
First posted: Oct 28, 2016
Start date: Dec 2016
Primary completion: Dec 2018 (estimated)
Last update: Oct 28, 2016

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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