Infertile Women Undergoing IVF or ICSISCLERENDONCT06878053
Benefit of Ethanol Sclerotherapy of Endometriomas Before Ovarian Stimulation on Pregnancy Rates in IVF/ICSI
A study testing ethanol sclerotherapy in people with Infertile Women Undergoing IVF or ICSI, run by Poissy-Saint Germain Hospital.
Trial summary
Evaluation of progressive pregnancy rates (with an embryo with cardiac activity at 12 weeks), on a first attempt at IVF/ICSI (fresh and frozen embryo transfers) following the discovery of one or two endometrioma(s) of 30 to 80 mm, without a history of cystectomy, and comparison between the two groups: ethanol… Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Infertile Women Undergoing IVF or ICSI
- What is being tested?
- ethanol sclerotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertile women aged 18 to 43,
- Presenting one or 2 endometriotic cysts of 30 mm to 80 mm long axis, confirmed by ultrasound and/or pelvic MRI and without signs of atypia,
- With indication of IVF/ICSI, first IVF/ICSI after the discovery of endometriosis cyst(s),
- Having given their consent.
Who cannot join
- A history of ovarian cystectomy,
- A non-homogeneous cyst that cannot be punctured (risk of incomplete aspiration),
- Complex adnexal image that cannot exclude an associated hematosalpinx (communicating hematosalpinx, tissue component),
- A recent tubo-ovarian infection,
- An active, untreated vaginal infection,
- Anticoagulant treatment at a therapeutic dose,
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- All adult patients protected by law (under guardianship or curatorship),
- Problems understanding the French language,
- Participation in intervention research,
- All patients not affiliated to the social security system.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Evaluation of progressive pregnancy rates (with an embryo with cardiac activity at 12 weeks), on a first attempt at IVF/ICSI (fresh and frozen embryo transfers) following the discovery of one or two endometrioma(s) of 30 to 80 mm, without a history of cystectomy, and comparison between the two groups: ethanol sclerotherapy and therapeutic abstention
- Conditions
- Infertile Women Undergoing IVF or ICSI
- Being tested
- ethanol sclerotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ethanol sclerotherapyProcedure or surgery
The originality of this project consists in evaluating the effectiveness of ethanol sclerotherapy of endometrioma(s) in infertile patients before IVF/ICSI, excluding patients who have previously had an ovarian cystectomy. To date, no prospective randomized comparative study between ethanol sclerotherapy of endometriomas and therapeutic abstention has been carried out.
| Study group | Role | What they receive |
|---|---|---|
| ethanol sclerotherapy group | Experimental | Not described Receives: Procedure: ethanol sclerotherapy |
| group without intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative rate of active pregnancies
Cumulative rate of active pregnancies defined by the presence of an embryo with cardiac activity at 12 weeks per IVF/ICSI cycle, including fresh and frozen embryo transfers in an IVF/ICSI attempt.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertile Women Undergoing IVF or ICSIStudies 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
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poissy-Saint Germain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nelly SWIERKOWSKI-BLANCHARD, MD, Poissy-Saint Germain Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878053
- Sponsor's protocol ID
- 2024-A02459-38
- Acronym
- SCLERENDO
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 14 Mar 2025
- 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 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Ethanol Sclerotherapy of Endometriomas Before Ovarian Stimulation on Pregnancy Rates in IVF/ICSI
- ClinicalTrials.gov ID
- NCT06878053
- Acronym / sponsor ID
- SCLERENDO / 2024-A02459-38
- Conditions
- Infertile Women Undergoing IVF or ICSI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Poissy-Saint Germain HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 14 Mar 2025 (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.
Evaluation of progressive pregnancy rates (with an embryo with cardiac activity at 12 weeks), on a first attempt at IVF/ICSI (fresh and frozen embryo transfers) following the discovery of one or two endometrioma(s) of 30 to 80 mm, without a history of cystectomy, and comparison between the two groups: ethanol sclerotherapy and therapeutic abstention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ethanol sclerotherapy group | Experimental | Procedure: ethanol sclerotherapy |
| group without intervention | No intervention | – |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Infertile women aged 18 to 43,
- Presenting one or 2 endometriotic cysts of 30 mm to 80 mm long axis, confirmed by ultrasound and/or pelvic MRI and without signs of atypia,
- With indication of IVF/ICSI, first IVF/ICSI after the discovery of endometriosis cyst(s),
- Having given their consent.
Key exclusion criteria (10 listed)
- A history of ovarian cystectomy,
- A non-homogeneous cyst that cannot be punctured (risk of incomplete aspiration),
- Complex adnexal image that cannot exclude an associated hematosalpinx (communicating hematosalpinx, tissue component),
- A recent tubo-ovarian infection,
- An active, untreated vaginal infection,
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 |
|---|---|---|
| ethanol sclerotherapyThe originality of this project consists in evaluating the effectiveness of ethanol sclerotherapy of endometrioma(s) in infertile patients before IVF/ICSI, excluding patients who have previously had an ovarian cystectomy. To date, no prospective randomized comparative study between ethanol sclerotherapy of endometriomas and therapeutic abstention has been carried out. | Procedure or surgery | ethanol sclerotherapy group |
Primary outcome
cumulative rate of active pregnancies
Time frame: 12 weeks
Cumulative rate of active pregnancies defined by the presence of an embryo with cardiac activity at 12 weeks per IVF/ICSI cycle, including fresh and frozen embryo transfers in an IVF/ICSI attempt.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing ethanol sclerotherapy in people with Infertile Women Undergoing IVF or ICSI, run by Poissy-Saint Germain 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 10 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: opening soon, as of the sponsor's last update on 14 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nelly SWIERKOWSKI-BLANCHARD, MD (+33139275259, nelly.swierkowskiblanchard@ght-yvelinesnord.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative rate of active pregnancies (time frame: 12 weeks). 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 14 Mar 2025.