Fetal Ovarian CystKOFNCT04526392
Pubertal Evolutionary Profile of Children Monitored for Fetal Ovarian Cyst
An observational study of Fetal Ovarian Cyst, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This study is based on pubertal surveillance of fetal ovarian cysts (KOF). Fetal ovarian cysts (KOF) detected during fetal ultrasound examinations occur during the 3rd trimester of pregnancy and are of unknown cause. Read more about this study
- Who is it for?
- Ages 8 to 18 years, women only
- Conditions the study is for
- Fetal Ovarian Cyst
- What is being tested?
- Questionnaire
- How many people
- 83 participants
- Where
- 1 siteFrance
- Study dates
- 6 Apr 2020to 30 Jul 2023
- Phase
- Observational
- 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 8 to 18 years
- Women only
- Child, Adult
Study population: Young girls who have to answer a questionnaire on their pubertal development. Estimated duration of data collection by questionnaire for one participant: 30 minutes maximum.
Who may be able to join
- Patients at least 8 years of age at the time of inclusion.
- Patients being followed for fetal ovarian cyst.
- Minor patients of whom at least one of the two holders of parental authority has given his or her non-opposition.
- Patients covered by a social security scheme.
Who cannot join
- Patients less than 8 years of age at the time of inclusion
- Ovarian cysts outside the neonatal period
- Refusal to participate.
- Opposition to disclosure of neonatal data.
- Pregnant or nursing patient.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Toulouse University Hospital
Toulouse, 31059
Catherine PIENKOWSKI, MD, 5 34 55 85 53 ext. +33, pienkowski.c@chu-toulouse.fr
Catherine PIENKOWSKI, MD
About this study
This study is based on pubertal surveillance of fetal ovarian cysts (KOF). Fetal ovarian cysts (KOF) detected during fetal ultrasound examinations occur during the 3rd trimester of pregnancy and are of unknown cause.
Read the detailed description
These cysts are functional in the vast majority of cases and are therefore likely to disappear spontaneously, but they may become complicated before regressing. Apart from complication, the natural evolution of these cysts, which are said to be "simple" because they are liquid on ultrasound, is towards regression in the first months of neo-natal life.
Surveillance during the 1st year of life showed that simple cysts regressed during the 1st trimester. In the case of complicated cysts, oophorectomy was necessary in 9 cases. In the 1-year follow-up, the ovarian recovery rate was significantly different depending on the appearance of the cyst (p<0.0001); 60 ovaries out of 89 homolateral to the cyst were follicular, of which 48/49 (98%) were carriers of fluid cysts and 12/40 (30%) were initially heterogeneous. The origin of these cysts is unknown, the ovary is again physiologically stimulated during the onset of puberty. No series in the literature gives the long-term ovarian prognosis for these patients. We wish to evaluate the pubertal evolutionary profile of patients followed at the University Hospital for KOF. The data collected concerning puberty (age of menses) will be examined in relation to the age of menses in the siblings and in the mother, as well as to the data in the literature on the age of the first menses in France.
- Conditions
- Fetal Ovarian Cyst
- Being tested
- Questionnaire
- Keywords
- child, puberty
- Medical subject headings
- Neonatal ovarian cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Pubertal course questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire | Patients will choose how they wish to complete the Pubertal Course Questionnaire: electronically (web link), on paper, by telephone, or face-to-face at a follow-up consultation. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age of onset of first menstruation
Age of onset of first menstruation defined with one decimal place (year and month).
Measured: Day 1
Secondary outcomes (14)
Average age of maternal and sister rules
Average age of maternal and sister menstruation.
Measured: Day 1
Ovarian volumes
Homo and contralateral ovarian volumes at the cyst.
Measured: Day 1
Presence or not of follicles
Presence or not of follicles on both ovaries.
Measured: Day 1
first menstruation description - age of breast onset
Age of breast onset
Measured: Day 1
first menstruation description - cycle length
cycle length in the last three months
Measured: Day 1
first menstruation description - cycle disorder
rate of patients with cycle disorder
Measured: Day 1
first menstruation description dysmenorrhoea.
dysmenorrhoea.
Measured: Day 1
first menstruation description menorrhagia
menorrhagia
Measured: Day 1
percentage of hyperandrogenism
Percentage of girls with clinical signs of hyperandrogenism or elevated testosterone levels.
Measured: Day 1
Hormonal levels - AMH
AMH levels
Measured: Day 1
Hormonal levels - LH
Luteinizing hormone (LH) levels
Measured: Day 1
Hormonal levels - FSH
follicle stimulating hormone (FSH) levels
Measured: Day 1
Hormonal levels - estradiol
estradiol levels
Measured: Day 1
rate of ovarian cyst recurrence
Ovarian cyst recurrence rate
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start6 Apr 2020
- Primary completion15 Apr 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Ovarian CystStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine PIENKOWSKI, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526392
- Sponsor's protocol ID
- RC31/19/0497
- Acronym
- KOF
- Status last verified
- Aug 2020
- First submitted
- 29 Jul 2020
- Last updated
- 25 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pubertal Evolutionary Profile of Children Monitored for Fetal Ovarian Cyst
- ClinicalTrials.gov ID
- NCT04526392
- Acronym / sponsor ID
- KOF / RC31/19/0497
- Conditions
- Fetal Ovarian Cyst
- Keywords
- child, puberty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 15 Apr 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 25 Aug 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.
This study is based on pubertal surveillance of fetal ovarian cysts (KOF). Fetal ovarian cysts (KOF) detected during fetal ultrasound examinations occur during the 3rd trimester of pregnancy and are of unknown cause.
Detailed description
These cysts are functional in the vast majority of cases and are therefore likely to disappear spontaneously, but they may become complicated before regressing. Apart from complication, the natural evolution of these cysts, which are said to be "simple" because they are liquid on ultrasound, is towards regression in the first months of neo-natal life.
Surveillance during the 1st year of life showed that simple cysts regressed during the 1st trimester. In the case of complicated cysts, oophorectomy was necessary in 9 cases. In the 1-year follow-up, the ovarian recovery rate was significantly different depending on the appearance of the cyst (p<0.0001); 60 ovaries out of 89 homolateral to the cyst were follicular, of which 48/49 (98%) were carriers of fluid cysts and 12/40 (30%) were initially heterogeneous. The origin of these cysts is unknown, the ovary is again physiologically stimulated during the onset of puberty. No series in the literature gives the long-term ovarian prognosis for these patients. We wish to evaluate the pubertal evolutionary profile of patients followed at the University Hospital for KOF. The data collected concerning puberty (age of menses) will be examined in relation to the age of menses in the siblings and in the mother, as well as to the data in the literature on the age of the first menses in France.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire | – | Other: QuestionnairePatients will choose how they wish to complete the Pubertal Course Questionnaire: electronically (web link), on paper, by telephone, or face-to-face at a follow-up consultation. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Young girls who have to answer a questionnaire on their pubertal development. Estimated duration of data collection by questionnaire for one participant: 30 minutes maximum.
Key inclusion criteria (4 listed)
- Patients at least 8 years of age at the time of inclusion.
- Patients being followed for fetal ovarian cyst.
- Minor patients of whom at least one of the two holders of parental authority has given his or her non-opposition.
- Patients covered by a social security scheme.
Key exclusion criteria (5 listed)
- Patients less than 8 years of age at the time of inclusion
- Ovarian cysts outside the neonatal period
- Refusal to participate.
- Opposition to disclosure of neonatal data.
- Pregnant or nursing patient.
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 |
|---|---|---|
| QuestionnairePubertal course questionnaire | Other | Questionnaire |
Primary outcome
Age of onset of first menstruation
Time frame: Day 1
Age of onset of first menstruation defined with one decimal place (year and month).
14 secondary outcomes
Average age of maternal and sister rules
Time frame: Day 1
Ovarian volumes
Time frame: Day 1
Presence or not of follicles
Time frame: Day 1
first menstruation description - age of breast onset
Time frame: Day 1
first menstruation description - cycle length
Time frame: Day 1
first menstruation description - cycle disorder
Time frame: Day 1
first menstruation description dysmenorrhoea.
Time frame: Day 1
first menstruation description menorrhagia
Time frame: Day 1
percentage of hyperandrogenism
Time frame: Day 1
Hormonal levels - AMH
Time frame: Day 1
Hormonal levels - LH
Time frame: Day 1
Hormonal levels - FSH
Time frame: Day 1
Hormonal levels - estradiol
Time frame: Day 1
rate of ovarian cyst recurrence
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- 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.
Catherine PIENKOWSKI, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Ovarian Cyst, run by University Hospital, Toulouse 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 4 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: status not confirmed, as of the sponsor's last update on 25 Aug 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine PIENKOWSKI, MD (5 34 55 85 53 ext. +33, pienkowski.c@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age of onset of first menstruation (time frame: Day 1). 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 25 Aug 2020.