Ovarian CystKYSTOVNCT02482467
Prognosis and Long Term Pubertal Outcome of Girls Previously Diagnosed With a Prenatal Ovarian Cyst
A study testing Hormonal analysis, pelvic US in people with Ovarian Cyst, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Puberty and long-term ovarian function of patients with a ovarian prenatal cyst has not described to date. Read more about this study
- Who is it for?
- Ages 6 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cyst
- What is being tested?
- Hormonal analysis, pelvic US
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2014to 7 May 2025
- 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 6 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Collection of the written consent by the patients or the parents
- Membership in a health insurance scheme
- Group 1 : girl with prenatal ovarian cyst group 2: girl without prenatal ovarian cyst
Who cannot join
- Refusal of participation of the patient or one of the two parents
- Deprived of freedom
- Pregnancy and current feeding
- Prenatal, neonatal or infantile history of ovarian pathology (Group 2)
- Genital congenital deformation or malformation syndrome gives a complex (group 2)
- Endocrine pathology except the juvenile disorders (group 2)
Trial locations and contacts
1 site in 1 country.
About this study
Puberty and long-term ovarian function of patients with a ovarian prenatal cyst has not described to date.
Read the detailed description
The prenatal diagnosis of ovarian cysts is a common disease with an estimated incidence of 1 case per 2500 births. This pathology is the first diagnosis of abdominal cystic picture on the female fetus in the third trimester of pregnancy.Various complications of ovarian cysts have been described, such as ovarian torsion, breaking the cyst, hemorrhage intra cystic and compression of adjacent viscera. A conservative attitude for uncomplicated cysts is proposed in the literature but surgical care and / or puncture can be made to prevent the occurrence of complications and thus to protect ovarian tissue.However, no data on puberty and long-term ovarian prognosis in this disease is published in the literature. Without this information, no support for the recommendation of a prenatal ovarian cyst can be established formally.
- Conditions
- Ovarian Cyst
- Being tested
- Hormonal analysis, pelvic US
- Keywords
- ovarian cyst, prenatal diagnosis, puberty
- Medical subject headings
- Ovarian Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormonal analysis, pelvic USOther
| Study group | Role | What they receive |
|---|---|---|
| Cases | Other | Prenatal diagnosis of ovarian cyst Receives: Other: Hormonal analysis, pelvic US |
| controls | Other | No prenatal diagnosis of cyst Receives: Other: Hormonal analysis, pelvic US |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age of puberty
Clinical data and clinical history
Measured: 1 day
Secondary outcomes (1)
Follicular reserve
Serum level of Anti-Mullerian Hormone and ovarian volume at ultrasonography
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study start24 Nov 2014
- Primary completion29 Mar 2021
- Study completion7 May 2025
Why it stopped: No difference between groups after analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CystStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas KALFA, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482467
- Sponsor's protocol ID
- 9434
- Other IDs
- 2014-A01025-42
- Acronym
- KYSTOV
- Status last verified
- May 2025
- First submitted
- 15 Jun 2015
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis and Long Term Pubertal Outcome of Girls Previously Diagnosed With a Prenatal Ovarian Cyst
- ClinicalTrials.gov ID
- NCT02482467
- Acronym / sponsor ID
- KYSTOV / 9434
- Conditions
- Ovarian Cyst
- Keywords
- ovarian cyst, prenatal diagnosis, puberty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No difference between groups after analysis
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 24 Nov 2014 (actual)
- Primary completion
- 29 Mar 2021 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 26 Jun 2015 (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.
Puberty and long-term ovarian function of patients with a ovarian prenatal cyst has not described to date.
Detailed description
The prenatal diagnosis of ovarian cysts is a common disease with an estimated incidence of 1 case per 2500 births. This pathology is the first diagnosis of abdominal cystic picture on the female fetus in the third trimester of pregnancy.Various complications of ovarian cysts have been described, such as ovarian torsion, breaking the cyst, hemorrhage intra cystic and compression of adjacent viscera. A conservative attitude for uncomplicated cysts is proposed in the literature but surgical care and / or puncture can be made to prevent the occurrence of complications and thus to protect ovarian tissue.However, no data on puberty and long-term ovarian prognosis in this disease is published in the literature. Without this information, no support for the recommendation of a prenatal ovarian cyst can be established formally.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | Other | Other: Hormonal analysis, pelvic USPrenatal diagnosis of ovarian cyst |
| controls | Other | Other: Hormonal analysis, pelvic USNo prenatal diagnosis of cyst |
Who may qualify
- Ages
- 6 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Collection of the written consent by the patients or the parents
- Membership in a health insurance scheme
- Group 1 : girl with prenatal ovarian cyst group 2: girl without prenatal ovarian cyst
Key exclusion criteria (6 listed)
- Refusal of participation of the patient or one of the two parents
- Deprived of freedom
- Pregnancy and current feeding
- Prenatal, neonatal or infantile history of ovarian pathology (Group 2)
- Genital congenital deformation or malformation syndrome gives a complex (group 2)
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 |
|---|---|---|
| Hormonal analysis, pelvic US | Other | Cases, controls |
Primary outcome
Age of puberty
Time frame: 1 day
Clinical data and clinical history
1 secondary outcome
Follicular reserve
Time frame: 1 day
Results and safety
The study was stopped early (reason given: No difference between groups after analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
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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.
Nicolas KALFA, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hormonal analysis, pelvic US in people with Ovarian Cyst, run by University Hospital, Montpellier at 1 site 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 3 inclusion and 6 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 16 May 2025. 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 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 was stopped early (reason given: No difference between groups after analysis). 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?
Age of puberty (time frame: 1 day). 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 16 May 2025.