Ovarian CystNCT00222066
Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion
A study testing Fetal ovarian cyst aspiration in people with Ovarian Cyst and Ultrasonography Prenatal, run by University Hospital, Tours at 3 sites in France.
Trial summary
The purpose of this study is to determine whether prenatal ovarian cyst aspiration is effective and safe to prevent perinatal ovarian torsion. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Ovarian Cyst, Ultrasonography Prenatal
- What is being tested?
- Fetal ovarian cyst aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 3 sitesFrance
- Study dates
- Jun 2001to Sep 2007
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women having an uneventful single pregnancy and a female fetus diagnosed with anechoic ovarian cyst (diameter at least 30mm)
Who cannot join
- Multiple pregnancy
- Complicated pregnancy (PE, diabetes, PROM, fetal malformation)
- Echoic cyst (fluid debris level, septated, retracting clot, globally echoic)
- Unability to give informed consent
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Caen
Caen
CHU de Nantes
Nantes, Loire Atl, 44000
Olympe de Gouges Women Health Centre, Bretonneau University Hospital
Tours, Centre-Val de Loire, 37044
About this study
Official title: Comparison Between Abstention and Intrauterine Aspiration in the Treatment of Anechoic Fetal Ovarian Cysts to Prevent Ovarian Torsion
The purpose of this study is to determine whether prenatal ovarian cyst aspiration is effective and safe to prevent perinatal ovarian torsion.
Read the detailed description
With the widespread use of routine sonography during pregnancy, the incidence of fetal ovarian cysts detected in utero has increased in the past decades. However
- Conditions
- Ovarian Cyst, Ultrasonography Prenatal
- Being tested
- Fetal ovarian cyst aspiration
- Keywords
- Aspiration, Fetal ovarian cyst, Ovarian torsion
- Medical subject headings
- Ovarian Cysts, Neonatal ovarian cyst, Ovarian Torsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal ovarian cyst aspirationProcedure or surgery
Fetal ovarian cyst aspiration performed under ultrasound guidance and maternal local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Fetal ovarian cyst aspiration performed as soon as possible Receives: Procedure: Fetal ovarian cyst aspiration |
| 2 | No intervention | Expectative |
What is being measured
The primary outcome is the main question the study is designed to answer.
To avoid neonatal surgery
Measured: 3 months after birth
Secondary outcomes (2)
Ultrasound pattern of neonatal ovarian cyst
Measured: 3 months after birth
Maternal and fetal/neonatal safety of prenatal ovarian cyst aspiration
Measured: 3 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2001
- Primary completionJan 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian CystStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Investigators
- Franck Perrotin, MD--PhD, Principal investigator, Tours University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222066
- Sponsor's protocol ID
- OV-UTERO 2000
- Status last verified
- Sep 2006
- First submitted
- 19 Sep 2005
- Last updated
- 3 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Perrotin F, Potin J, Haddad G, Sembely-Taveau C, Lansac J, Body G. Fetal ovarian cysts: a report of three cases managed by intrauterine aspiration. Ultrasound Obstet Gynecol. 2000 Dec;16(7):655-9. doi: 10.1046/j.1469-0705.2000.00247.x.
PubMed 11169374Perrotin F, Roy F, Potin J, Lardy H, Lansac J, Body G. [Ultrasonographic diagnosis and prenatal management of fetal ovarian cysts]. J Gynecol Obstet Biol Reprod (Paris). 2000 Apr;29(2):161-9. French.
PubMed 10790628
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Abstention and Intrauterine Aspiration in the Treatment of Anechoic Fetal Ovarian Cysts to Prevent Ovarian Torsion
- ClinicalTrials.gov ID
- NCT00222066
- Acronym / sponsor ID
- OV-UTERO 2000
- Conditions
- Ovarian Cyst, Ultrasonography Prenatal
- Keywords
- Aspiration, Fetal ovarian cyst, Ovarian torsion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Jun 2001
- Primary completion
- Jan 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 22 Sep 2005 (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 purpose of this study is to determine whether prenatal ovarian cyst aspiration is effective and safe to prevent perinatal ovarian torsion.
Detailed description
With the widespread use of routine sonography during pregnancy, the incidence of fetal ovarian cysts detected in utero has increased in the past decades. However
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Fetal ovarian cyst aspirationFetal ovarian cyst aspiration performed as soon as possible |
| 2 | No intervention | –Expectative |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women having an uneventful single pregnancy and a female fetus diagnosed with anechoic ovarian cyst (diameter at least 30mm)
Key exclusion criteria (4 listed)
- Multiple pregnancy
- Complicated pregnancy (PE, diabetes, PROM, fetal malformation)
- Echoic cyst (fluid debris level, septated, retracting clot, globally echoic)
- Unability to give informed consent
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 |
|---|---|---|
| Fetal ovarian cyst aspirationFetal ovarian cyst aspiration performed under ultrasound guidance and maternal local anesthesia | Procedure or surgery | 1 |
Primary outcome
To avoid neonatal surgery
Time frame: 3 months after birth
2 secondary outcomes
Ultrasound pattern of neonatal ovarian cyst
Time frame: 3 months after birth
Maternal and fetal/neonatal safety of prenatal ovarian cyst aspiration
Time frame: 3 months after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2010.
- Background: PubMed 11169374Perrotin F, Potin J, Haddad G, Sembely-Taveau C, Lansac J, Body G. Fetal ovarian cysts: a report of three cases managed by intrauterine aspiration. Ultrasound Obstet Gynecol. 2000 Dec;16(7):655-9. doi: 10.1046/j.1469-0705.2000.00247.x.
- Background: PubMed 10790628Perrotin F, Roy F, Potin J, Lardy H, Lansac J, Body G. [Ultrasonographic diagnosis and prenatal management of fetal ovarian cysts]. J Gynecol Obstet Biol Reprod (Paris). 2000 Apr;29(2):161-9. French.
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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.
Franck Perrotin, MD--PhD principal investigator
Tours University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetal ovarian cyst aspiration in people with Ovarian Cyst and Ultrasonography Prenatal, run by University Hospital, Tours at 3 sites in France.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 3 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To avoid neonatal surgery (time frame: 3 months after birth). 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 NCT00222066, which also lists 2 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 3 Feb 2010.