Quality of LifeNCT01910584
Quality of Life and Sexual Function of the Novasure Endometrial Ablation in Menorrhagia
An observational study of Quality of Life and Sexual Activity, run by Shu-Qin Chen at 1 site in China.
Trial summary
The aim of this study is to investigate the influence on the quality of life and sexual function before, 6 month and one year after Novasure Endometrial Ablation in the treatment of Menorrhagia. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Quality of Life, Sexual Activity
- What is being tested?
- Novasure endometrial ablation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Nov 2015
- Phase
- Observational
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: 100 patients diagnosed menorrhagia scheduled for Novasure endometrial ablation in The First Affiliated Hospital between November 2012 and November 2015
Who may be able to join
- clinical diagnosis of menorrhagia
- family complete
- normal endometrial pathology
- had not been referred specifically for surgery
- with normal uterine cavity
Who cannot join
- pregnancy or demand to preserve fertility
- acute reproductive tract inflammation or urinary tract inflammation
- pathology demonstrate endometrial cancer or precancerous change
- acute pelvic inflammation
- intrauterine device(IUD) in uterus
- depth of uterine cavity less than 4cm or more than 10cm
- pathologic myometrium( such as history of Hysteromyomectomy or classical cesarean section)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun yat-sen University
Guangzhou, Guangdong, 510080
Shu-Qin Chen, PhD & M.D, +862087332200 ext. 8342, chenshuqin1021@163.com
Jin-bo Li, M.D, +862087332200 ext. 8342, bobolee2004@aliyun.com
About this study
Official title: Prospective Study of the Influence on Quality of Life and Sexual Function of the Novasure Endometrial Ablation in the Treatment of Menorrhagia
The aim of this study is to investigate the influence on the quality of life and sexual function before, 6 month and one year after Novasure Endometrial Ablation in the treatment of Menorrhagia.
Read the detailed description
patients diagnosed menorrhagia scheduled for Novasure Endometrial Ablation because of menorrhagia between november, 2012 and november, 2014 are enrolled to this study.
patients are asked to complete preoperative questionnaires considering Health Related Quality of Life questionnaire(HRQoL) and sexual Female Sexual Functioning Index questionnaire(FSFI). Same questionnaires will also be completed six months and one year after operation.
- Conditions
- Quality of Life, Sexual Activity
- Being tested
- Novasure endometrial ablation
- Keywords
- quality of life, sexual activity, Novasure endometrial ablation, menorrhagia
- Medical subject headings
- Sexual Behavior, Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novasure endometrial ablationProcedure or surgery
Novasure endometrial ablation is the second generation endometrial ablation treatment aimed to cure the dysfunctional uterine bleeding(DUB),including menorrhagia.
| Study group | Role | What they receive |
|---|---|---|
| Novasure treated group | patients diagnosed menorrhea were treated with novasure endometrial ablation Receives: Procedure: Novasure endometrial ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life and Sexual Function before, six month and one year after the Novasure Endometrial Ablation
Quality of life assessed with Health Related Quality of Life questionnaire(HRQoL) before, six month and one year after the Novasure Endometrial Ablation; Sexual Function measured with Female Sexual Functioning Index questionnaire(FSFI) before, six month and one year after the Novasure Endometrial Ablation
Measured: one year after Novasure Endometrial Ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study startNov 2012
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shu-Qin Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shu-Qin Chen, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Shu-Zhong Yao, PhD & MD, Study director, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910584
- Sponsor's protocol ID
- First-GYN-SYSU-2012
- Status last verified
- Sep 2012
- First submitted
- 20 Jul 2013
- Last updated
- 29 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Influence on Quality of Life and Sexual Function of the Novasure Endometrial Ablation in the Treatment of Menorrhagia
- ClinicalTrials.gov ID
- NCT01910584
- Acronym / sponsor ID
- First-GYN-SYSU-2012
- Conditions
- Quality of Life, Sexual Activity
- Keywords
- quality of life, sexual activity, Novasure endometrial ablation, menorrhagia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shu-Qin ChenUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 29 Jul 2013 (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.
The aim of this study is to investigate the influence on the quality of life and sexual function before, 6 month and one year after Novasure Endometrial Ablation in the treatment of Menorrhagia.
Detailed description
patients diagnosed menorrhagia scheduled for Novasure Endometrial Ablation because of menorrhagia between november, 2012 and november, 2014 are enrolled to this study.
patients are asked to complete preoperative questionnaires considering Health Related Quality of Life questionnaire(HRQoL) and sexual Female Sexual Functioning Index questionnaire(FSFI). Same questionnaires will also be completed six months and one year after operation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novasure treated group | – | Procedure: Novasure endometrial ablationpatients diagnosed menorrhea were treated with novasure endometrial ablation |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 100 patients diagnosed menorrhagia scheduled for Novasure endometrial ablation in The First Affiliated Hospital between November 2012 and November 2015
Key inclusion criteria (5 listed)
- clinical diagnosis of menorrhagia
- family complete
- normal endometrial pathology
- had not been referred specifically for surgery
- with normal uterine cavity
Key exclusion criteria (7 listed)
- pregnancy or demand to preserve fertility
- acute reproductive tract inflammation or urinary tract inflammation
- pathology demonstrate endometrial cancer or precancerous change
- acute pelvic inflammation
- intrauterine device(IUD) in uterus
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 |
|---|---|---|
| Novasure endometrial ablationNovasure endometrial ablation is the second generation endometrial ablation treatment aimed to cure the dysfunctional uterine bleeding(DUB),including menorrhagia. | Procedure or surgery | Novasure treated group |
Primary outcome
Quality of life and Sexual Function before, six month and one year after the Novasure Endometrial Ablation
Time frame: one year after Novasure Endometrial Ablation
Quality of life assessed with Health Related Quality of Life questionnaire(HRQoL) before, six month and one year after the Novasure Endometrial Ablation; Sexual Function measured with Female Sexual Functioning Index questionnaire(FSFI) before, six month and one year after the Novasure Endometrial Ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2013.
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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.
Shu-Zhong Yao, PhD & MD study director
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Sexual Activity, run by Shu-Qin Chen at 1 site in China.
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 5 inclusion and 7 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 29 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Shu-Qin Chen, PhD & MD (+862087332200 ext. 8342, chenshuqin1021@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life and Sexual Function before, six month and one year after the Novasure Endometrial Ablation (time frame: one year after Novasure Endometrial Ablation). 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 29 Jul 2013.