Tubal LigationNCT04663568
Levonorgestrel-releasing Intrauterine System and Tubal Ligation
A study testing Levonorgestrel-releasing intrauterine system in people with Tubal Ligation, run by Assiut University at 1 site in Egypt.
Trial summary
Today tubal sterilization is a simple, safe, and cost-effective method of achieving long-term contraception. Sterilization is an ideal method of permanent contraception in developing countries where access to health care providers is limited. Read more about this study
- Who is it for?
- Ages 30 to 45 years, women only
- Conditions the study is for
- Tubal Ligation
- What is being tested?
- Levonorgestrel-releasing intrauterine system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 1 Dec 2021
- 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 30 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged from 30-40 year
- Woman subjected to tubal ligation
- Women 12 month postpartum
- Non lactating women
- Nomedical disorders
Who cannot join
- contraindication for Levonorgestrel-releasing Intrauterine System
- Women with any uterine or ovarian pathology
- women refuse to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Levonorgestrel-releasing Intrauterine System: A Emerging Tool for Conservative Treatment of Pain and Bleeding After Tubal Ligation
Today tubal sterilization is a simple, safe, and cost-effective method of achieving long-term contraception. Sterilization is an ideal method of permanent contraception in developing countries where access to health care providers is limited. The percentage of women who use sterilization as a method of contraception rises from about 5% between 20 and 24 years of age to almost 50% for those between 40 and 44 years of age. The most widely touted and most significant health benefit of tubal sterilization appears to be a reduced risk of ovarian cancer.
Post-tubal ligation syndrome includes pain during intercourse, aching lower back, premenstrual tension syndrome, uterine hemorrhage, and absence of menstruation. The syndrome is caused by blood circulation problems in and around the Fallopian tubes and ovaries, pressure on nerves, and intrapelvic adhesion. Since the symptoms of this syndrome are mild, simple symptomatic treatment is sufficient in most cases. In some cases, however, hysterectomy may be necessary.
- Conditions
- Tubal Ligation
- Being tested
- Levonorgestrel-releasing intrauterine system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel-releasing intrauterine systemDevice
Levonorgestrel-releasing intrauterine system will be inserted during the menstrual cycle
| Study group | Role | What they receive |
|---|---|---|
| Levonorgestrel-releasing intrauterine system | Other | Not described Receives: Device: Levonorgestrel-releasing intrauterine system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of pain from before to 6 months after levonorgestrel-releasing intrauterine system insertion
visual analogue scale from 0 (minimum value) to 10 (maximum value)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Dec 2020
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Why it stopped: No fund was obtained for buying the hormonal IUD
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tubal LigationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663568
- Sponsor's protocol ID
- LNG_TS
- Status last verified
- Nov 2022
- First submitted
- 5 Dec 2020
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levonorgestrel-releasing Intrauterine System: A Emerging Tool for Conservative Treatment of Pain and Bleeding After Tubal Ligation
- ClinicalTrials.gov ID
- NCT04663568
- Acronym / sponsor ID
- LNG_TS
- Conditions
- Tubal Ligation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No fund was obtained for buying the hormonal IUD
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 11 Dec 2020 (actual)
- 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.
Today tubal sterilization is a simple, safe, and cost-effective method of achieving long-term contraception. Sterilization is an ideal method of permanent contraception in developing countries where access to health care providers is limited. The percentage of women who use sterilization as a method of contraception rises from about 5% between 20 and 24 years of age to almost 50% for those between 40 and 44 years of age. The most widely touted and most significant health benefit of tubal sterilization appears to be a reduced risk of ovarian cancer.
Post-tubal ligation syndrome includes pain during intercourse, aching lower back, premenstrual tension syndrome, uterine hemorrhage, and absence of menstruation. The syndrome is caused by blood circulation problems in and around the Fallopian tubes and ovaries, pressure on nerves, and intrapelvic adhesion. Since the symptoms of this syndrome are mild, simple symptomatic treatment is sufficient in most cases. In some cases, however, hysterectomy may be necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levonorgestrel-releasing intrauterine system | Other | Device: Levonorgestrel-releasing intrauterine system |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged from 30-40 year
- Woman subjected to tubal ligation
- Women 12 month postpartum
- Non lactating women
- Nomedical disorders
Key exclusion criteria (3 listed)
- contraindication for Levonorgestrel-releasing Intrauterine System
- Women with any uterine or ovarian pathology
- women refuse to participate
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 |
|---|---|---|
| Levonorgestrel-releasing intrauterine systemLevonorgestrel-releasing intrauterine system will be inserted during the menstrual cycle | Device | Levonorgestrel-releasing intrauterine system |
Primary outcome
The level of pain from before to 6 months after levonorgestrel-releasing intrauterine system insertion
Time frame: 6 months
visual analogue scale from 0 (minimum value) to 10 (maximum value)
Results and safety
The study was stopped early (reason given: No fund was obtained for buying the hormonal IUD). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Tubal Ligation
Recruiting
Using the CompuFlo® CathCheck™ System to Check Epidural Catheter Function Before Tubal Ligation: A Pilot Study
Anesthesia, Epidural
Enrolling by invitationObservational study
Stop Ovarian Cancer Young; Effect of the Opportunistic Salpingectomy on Age of Menopause
Salpingectomy, Tubal Ligation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levonorgestrel-releasing intrauterine system in people with Tubal Ligation, run by Assiut University at 1 site in Egypt.
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 3 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: stopped early, as of the sponsor's last update on 30 Nov 2022. 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 Egypt. 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?
The study was stopped early (reason given: No fund was obtained for buying the hormonal IUD). 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?
The level of pain from before to 6 months after levonorgestrel-releasing intrauterine system insertion (time frame: 6 months). 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 30 Nov 2022.