Infertility, FemaleNCT02948205
Analysis of TU-LESS by 3D Laparoscopy in the Treatment of Infertility
A study testing 3D group and normal group in people with Infertility, Female, run by Shanghai First Maternity and Infant Hospital.
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… Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- 3D group and normal group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients are younger than 36 and older than 24.
- Clearly diagnosed with female Infertility.
- Infertility within 1 to 10 years.
- informed consent form signed
Who cannot join
- 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.
About this study
Official title: Analysis of Trans-umbilical Laparoendoscopic Single-site Surgery by 3D Laparoscopy in the Treatment of Infertility
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
- Infertility, Female
- Being tested
- 3D group, normal group
- Keywords
- Infertility, TU-LESS, 3D laparoscopy
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D groupProcedure or surgery
infertility patient get TU-LESS by 3D Laparoscopy
normal groupProcedure or surgery
infertility patient get normal laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| 3D group | Experimental | infertility patient get TU-LESS by 3D Laparoscopy Receives: Procedure: 3D group |
| normal group | Other | infertility patient get normal laparoscopic surgery Receives: Procedure: normal group |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
Visual Analogue Score for the pain feeling of the patient
Measured: in 24 hours after surgery
pregnancy rate
Measured: 6 months after surgery
Secondary outcomes (1)
Operation time
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948205
- Sponsor's protocol ID
- ShanghaiFMIH-3D
- Status last verified
- Oct 2016
- First submitted
- 25 Oct 2016
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Trans-umbilical Laparoendoscopic Single-site Surgery by 3D Laparoscopy in the Treatment of Infertility
- ClinicalTrials.gov ID
- NCT02948205
- Acronym / sponsor ID
- ShanghaiFMIH-3D
- Conditions
- Infertility, Female
- Keywords
- Infertility, TU-LESS, 3D laparoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (estimated)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D group | Experimental | Procedure: 3D groupinfertility patient get TU-LESS by 3D Laparoscopy |
| normal group | Other | Procedure: normal groupinfertility patient get normal laparoscopic surgery |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients are younger than 36 and older than 24.
- Clearly diagnosed with female Infertility.
- Infertility within 1 to 10 years.
- informed consent form signed
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D groupinfertility patient get TU-LESS by 3D Laparoscopy | Procedure or surgery | 3D group |
| normal groupinfertility patient get normal laparoscopic surgery | Procedure or surgery | normal group |
Primary outcome
pain score
Time frame: in 24 hours after surgery
Visual Analogue Score for the pain feeling of the patient
pregnancy rate
Time frame: 6 months after surgery
1 secondary outcome
Operation time
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 3D group and normal group in people with Infertility, Female, run by Shanghai First Maternity and Infant Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score (time frame: in 24 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.