ContraceptionJANESSNCT03708809
Immediate Versus Delayed Initiation of Intrauterine System
A study testing Intrauterine system and Alternative contraception to intrauterine system in people with Contraception, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Contraception for teenagers and young adults presents a huge challenge for the clinician as more than half of all unintended pregnancies occur as a result of inconsistent or discontinued use of contraceptives . Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Intrauterine system and Alternative contraception to intrauterine system
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2023to 1 Aug 2026
- 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 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women that are about to go through surgical termination of first trimester pregnancy
- Age ≥ 18 years
- Nulliparous
Who cannot join
- structural uterine abnormality
- submucosal fibroids
- suspected uterine or cervical neoplasia
- acute pelvic inflammatory disease
- acute liver disease or previous breast cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Versus Delayed Initiation of the 13.5 mg Levonorgestrel-releasing Intrauterine System Following Surgical Termination of Pregnancy
Contraception for teenagers and young adults presents a huge challenge for the clinician as more than half of all unintended pregnancies occur as a result of inconsistent or discontinued use of contraceptives . Possible solution is promoting the use of long acting reversible contraception, (LARC) among them the intrauterine device (IUD). IUD provide safe, highly effective, long-term contraception. Immediate IUD insertion after the termination of pregnancy (TOP) is a very convenient way to provide contraception as it is an opportune moment to carry out this short, easy, and safe procedure.
Janess is a T-shaped intrauterine delivery system that was introduced lately, which slowly releases a small amount (13.5 mg) of levonorgestrel after its installation inside the womb and provides contraception for up to three years.
The aim of this study to compare insertion of 13.5 mg levonorgestrel-releasing intrauterine system after surgical abortion immediately versus delayed insertion (at menstruation)
Read the detailed description
The rate of repeat induced abortion varies from 30% to 38% in northern Europe. Young women, parous women and those with a history of abortion were found to be the main risk factors associated with recurrent termination of pregnancy. Young women may lack knowledge or access to conventional methods of preventing pregnancy, as they may be too embarrassed or frightened to seek such information. Contraception for teenagers and young adults presents a huge challenge for the clinician as more than half of all unintended pregnancies occur as a result of inconsistent or discontinued use of contraceptives . Possible solution is promoting the use of long acting reversible contraception, (LARC) among them the intrauterine device (IUD), that was found well suited even for adolescents. Because IUDs do not require active use once they have been inserted, and have a very low failure rate, their increased use has the potential to substantially reduce unintended pregnancies. IUD provide safe, highly effective, long-term contraception, but they are underused.
Immediate initiation of any contraceptive method after an abortion has been linked to a reduced risk of repeat abortion. Immediate IUD insertion after the termination of pregnancy (TOP) is a very convenient way to provide contraception as it is an opportune moment to carry out this short, easy, and safe procedure. As the cervix is dilated, insertion is virtually painless. Following insertion, the woman is protected immediately, before ovulation returns, usually within 7-10 days after first-trimester abortion.
Lately, a new intrauterine device directed for young women was introduced. It is a T-shaped intrauterine delivery system which slowly releases a small amount (13.5 mg) of levonorgestrel after its installation inside the womb. The system is intended for contraception for a period of up to 3 years. It works by reducing the monthly growth of the lining of the womb and thickening of the cervical mucosal layer.
To the best of the investigator's knowledge this is the first study to compare insertion of 13.5 mg levonorgestrel-releasing intrauterine system after surgical abortion immediately versus delayed insertion (at menstruation) .
- Conditions
- Contraception
- Being tested
- Intrauterine system, Alternative contraception to intrauterine system
- Keywords
- IUD, contraception, levonogestral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine systemDevice
Also called Janess
13.5 mg levonorgestrel-releasing intrauterine system
Alternative contraception to intrauterine systemOther
Alternative contraception including contraception pills, hormonal patches, hormonal vaginal , condomsring,
| Study group | Role | What they receive |
|---|---|---|
| Immediate insertion | Experimental | The intrauterine system will be inserted immediately after surgical termination of pregnancy, before awakening from anesthesia Receives: Device: Intrauterine system |
| Delayed insertion | Experimental | The intrauterine system will be inserted on the first menstruation after termination of pregnancy. Women allocated to this arm will be asked to contact the study coordinator in order to visit the hospital on the proper timing for IUD insertion. Receives: Device: Intrauterine system |
| Control | Other | Women who refuse to actively participate in the intervention groups will be offered consultation on other options for contraception during gynecological clinic visit after fist menstruation from termination of pregnancy. Receives: Other: Alternative contraception to intrauterine system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuation rate after one year from insertion
Measured: estimated time of one year follow up from insertion
Secondary outcomes (1)
Expulsion rate
Measured: On first visit after menstruation from insertion, 3 month from insertion and after one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start1 Dec 2023 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Why it stopped: could not be funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Dr. Aya Mohr-Sasson, Sheba Medical Center
- Investigators
- Aya Mohr Sasson, M.D, Principal investigator, Sheba Medical Center, Tel-Hashomer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708809
- Sponsor's protocol ID
- 4671-17-SMC
- Acronym
- JANESS
- Status last verified
- Nov 2024
- First submitted
- 14 Oct 2018
- Last updated
- 14 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Heikinheimo O, Gissler M, Suhonen S. Age, parity, history of abortion and contraceptive choices affect the risk of repeat abortion. Contraception. 2008 Aug;78(2):149-54. doi: 10.1016/j.contraception.2008.03.013. Epub 2008 May 27.
PubMed 18672117Apter D. Contraception options: Aspects unique to adolescent and young adult. Best Pract Res Clin Obstet Gynaecol. 2018 Apr;48:115-127. doi: 10.1016/j.bpobgyn.2017.09.010. Epub 2017 Sep 28.
PubMed 29032945Hubacher D, Cheng D. Intrauterine devices and reproductive health: American women in feast and famine. Contraception. 2004 Jun;69(6):437-46. doi: 10.1016/j.contraception.2004.01.009.
PubMed 15157788Goodman S, Hendlish SK, Reeves MF, Foster-Rosales A. Impact of immediate postabortal insertion of intrauterine contraception on repeat abortion. Contraception. 2008 Aug;78(2):143-8. doi: 10.1016/j.contraception.2008.03.003. Epub 2008 May 14.
PubMed 18672116Lahteenmaki P, Luukkainen T. Return of ovarian function after abortion. Clin Endocrinol (Oxf). 1978 Feb;8(2):123-32. doi: 10.1111/j.1365-2265.1978.tb02160.x.
PubMed 630723
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Versus Delayed Initiation of the 13.5 mg Levonorgestrel-releasing Intrauterine System Following Surgical Termination of Pregnancy
- ClinicalTrials.gov ID
- NCT03708809
- Acronym / sponsor ID
- JANESS / 4671-17-SMC
- Conditions
- Contraception
- Keywords
- IUD, contraception, levonogestral
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: could not be funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Bayer
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 17 Oct 2018 (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.
Contraception for teenagers and young adults presents a huge challenge for the clinician as more than half of all unintended pregnancies occur as a result of inconsistent or discontinued use of contraceptives . Possible solution is promoting the use of long acting reversible contraception, (LARC) among them the intrauterine device (IUD). IUD provide safe, highly effective, long-term contraception. Immediate IUD insertion after the termination of pregnancy (TOP) is a very convenient way to provide contraception as it is an opportune moment to carry out this short, easy, and safe procedure.
Janess is a T-shaped intrauterine delivery system that was introduced lately, which slowly releases a small amount (13.5 mg) of levonorgestrel after its installation inside the womb and provides contraception for up to three years.
The aim of this study to compare insertion of 13.5 mg levonorgestrel-releasing intrauterine system after surgical abortion immediately versus delayed insertion (at menstruation)
Detailed description
The rate of repeat induced abortion varies from 30% to 38% in northern Europe. Young women, parous women and those with a history of abortion were found to be the main risk factors associated with recurrent termination of pregnancy. Young women may lack knowledge or access to conventional methods of preventing pregnancy, as they may be too embarrassed or frightened to seek such information. Contraception for teenagers and young adults presents a huge challenge for the clinician as more than half of all unintended pregnancies occur as a result of inconsistent or discontinued use of contraceptives . Possible solution is promoting the use of long acting reversible contraception, (LARC) among them the intrauterine device (IUD), that was found well suited even for adolescents. Because IUDs do not require active use once they have been inserted, and have a very low failure rate, their increased use has the potential to substantially reduce unintended pregnancies. IUD provide safe, highly effective, long-term contraception, but they are underused.
Immediate initiation of any contraceptive method after an abortion has been linked to a reduced risk of repeat abortion. Immediate IUD insertion after the termination of pregnancy (TOP) is a very convenient way to provide contraception as it is an opportune moment to carry out this short, easy, and safe procedure. As the cervix is dilated, insertion is virtually painless. Following insertion, the woman is protected immediately, before ovulation returns, usually within 7-10 days after first-trimester abortion.
Lately, a new intrauterine device directed for young women was introduced. It is a T-shaped intrauterine delivery system which slowly releases a small amount (13.5 mg) of levonorgestrel after its installation inside the womb. The system is intended for contraception for a period of up to 3 years. It works by reducing the monthly growth of the lining of the womb and thickening of the cervical mucosal layer.
To the best of the investigator's knowledge this is the first study to compare insertion of 13.5 mg levonorgestrel-releasing intrauterine system after surgical abortion immediately versus delayed insertion (at menstruation) .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immediate insertion | Experimental | Device: Intrauterine systemThe intrauterine system will be inserted immediately after surgical termination of pregnancy, before awakening from anesthesia |
| Delayed insertion | Experimental | Device: Intrauterine systemThe intrauterine system will be inserted on the first menstruation after termination of pregnancy. Women allocated to this arm will be asked to contact the study coordinator in order to visit the hospital on the proper timing for IUD insertion. |
| Control | Other | Other: Alternative contraception to intrauterine systemWomen who refuse to actively participate in the intervention groups will be offered consultation on other options for contraception during gynecological clinic visit after fist menstruation from termination of pregnancy. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women that are about to go through surgical termination of first trimester pregnancy
- Age ≥ 18 years
- Nulliparous
Key exclusion criteria (5 listed)
- structural uterine abnormality
- submucosal fibroids
- suspected uterine or cervical neoplasia
- acute pelvic inflammatory disease
- acute liver disease or previous breast cancer
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 |
|---|---|---|
| Intrauterine systemAlso: Janess13.5 mg levonorgestrel-releasing intrauterine system | Device | Delayed insertion, Immediate insertion |
| Alternative contraception to intrauterine systemAlternative contraception including contraception pills, hormonal patches, hormonal vaginal , condomsring, | Other | Control |
Primary outcome
Continuation rate after one year from insertion
Time frame: estimated time of one year follow up from insertion
1 secondary outcome
Expulsion rate
Time frame: On first visit after menstruation from insertion, 3 month from insertion and after one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Results publication: PubMed 18672117Heikinheimo O, Gissler M, Suhonen S. Age, parity, history of abortion and contraceptive choices affect the risk of repeat abortion. Contraception. 2008 Aug;78(2):149-54. doi: 10.1016/j.contraception.2008.03.013. Epub 2008 May 27.
- Results publication: PubMed 29032945Apter D. Contraception options: Aspects unique to adolescent and young adult. Best Pract Res Clin Obstet Gynaecol. 2018 Apr;48:115-127. doi: 10.1016/j.bpobgyn.2017.09.010. Epub 2017 Sep 28.
- Results publication: PubMed 15157788Hubacher D, Cheng D. Intrauterine devices and reproductive health: American women in feast and famine. Contraception. 2004 Jun;69(6):437-46. doi: 10.1016/j.contraception.2004.01.009.
- Results publication: PubMed 18672116Goodman S, Hendlish SK, Reeves MF, Foster-Rosales A. Impact of immediate postabortal insertion of intrauterine contraception on repeat abortion. Contraception. 2008 Aug;78(2):143-8. doi: 10.1016/j.contraception.2008.03.003. Epub 2008 May 14.
- Results publication: PubMed 630723Lahteenmaki P, Luukkainen T. Return of ovarian function after abortion. Clin Endocrinol (Oxf). 1978 Feb;8(2):123-32. doi: 10.1111/j.1365-2265.1978.tb02160.x.
- 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.
Aya Mohr Sasson, M.D principal investigator
Sheba Medical Center, Tel-Hashomer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrauterine system and Alternative contraception to intrauterine system in people with Contraception, run by Sheba Medical Center at 1 site in Israel.
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 3 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: withdrawn, as of the sponsor's last update on 14 Nov 2024. 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 Israel. 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 withdrawn before enrolling participants, so there are no results.
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?
Continuation rate after one year from insertion (time frame: estimated time of one year follow up from insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03708809, which also lists 5 linked publications.
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 14 Nov 2024.