Polycystic Ovary SyndromePAEONNCT02098668
Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON
An observational study of Polycystic Ovary Syndrome and Endometriosis, run by University of Zurich at 1 site in Switzerland.
Trial summary
Development of a bio-mathematical model of the human female cycle Read more about this study
- Who is it for?
- Ages 18 months to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Endometriosis, Hyperprolactinemia
- What is being tested?
- Fertility treatment
- How many people
- 123 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2013to Apr 2016
- 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 18 months to 43 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Women with normal and distrubed menstrual cycles Women receiving fertility treatment
Who may be able to join
- Women during their reproductive phase, no hormonal therapy
Who cannot join
- Amenorrhoae
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Reproductive Endocrinology
Zurich, Canton of Zurich, 8091
About this study
Official title: Model Driven Computation for Infertility Related Endocrinological Diseases - PAEON
Development of a bio-mathematical model of the human female cycle
Read the detailed description
From hormonal measurements throughout 1-2 menstrual cycles in women with and without endocrinological pathology a mathematical model of the human menstrual cycle will be generated. The model will serve to predict development of the cycle including ovulation as well as to better understand the pathophysiology of endocrinological disorder. In a second step current treatment protocols for fertility treatment will be integrated into the model in order to optimize treatment outcome.
- Conditions
- Polycystic Ovary Syndrome, Endometriosis, Hyperprolactinemia
- Being tested
- Fertility treatment
- Keywords
- menstrual cycle dynamics, PCOS, hyperprolactinemia, endometriosis, infertility
- Medical subject headings
- Polycystic Ovary Syndrome, Endometriosis, Hyperprolactinemia, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fertility treatmentOther
Fertility treatment
| Study group | Role | What they receive |
|---|---|---|
| Normal, pathological cycle, infertility | healthy women PCOS Endometriosis hyperprolactinemia fertility treatment Receives: Other: Fertility treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hormonal parameters
Development of a mathematical model of the menstrual cycle
Measured: 3 years
Secondary outcomes (1)
Dynamics of fertility treatment
Mathematical model to improve fertility treatments
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startSep 2013
- Primary completionFeb 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigitte Leeners, MD, Principal investigator, University Hospital Zurich, Division of Reproductive Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098668
- Sponsor's protocol ID
- 17721_PAEON
- Acronym
- PAEON
- Status last verified
- Sep 2016
- First submitted
- 18 Jun 2013
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Leeners B, Kruger THC, Geraedts K, Tronci E, Mancini T, Egli M, Roblitz S, Saleh L, Spanaus K, Schippert C, Zhang Y, Ille F. Associations Between Natural Physiological and Supraphysiological Estradiol Levels and Stress Perception. Front Psychol. 2019 Jun 11;10:1296. doi: 10.3389/fpsyg.2019.01296. eCollection 2019.
PubMed 31244718
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model Driven Computation for Infertility Related Endocrinological Diseases - PAEON
- ClinicalTrials.gov ID
- NCT02098668
- Acronym / sponsor ID
- PAEON / 17721_PAEON
- Conditions
- Polycystic Ovary Syndrome, Endometriosis, Hyperprolactinemia
- Keywords
- menstrual cycle dynamics, PCOS, hyperprolactinemia, endometriosis, infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 28 Mar 2014 (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.
Development of a bio-mathematical model of the human female cycle
Detailed description
From hormonal measurements throughout 1-2 menstrual cycles in women with and without endocrinological pathology a mathematical model of the human menstrual cycle will be generated. The model will serve to predict development of the cycle including ovulation as well as to better understand the pathophysiology of endocrinological disorder. In a second step current treatment protocols for fertility treatment will be integrated into the model in order to optimize treatment outcome.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal, pathological cycle, infertility | – | Other: Fertility treatmenthealthy women PCOS Endometriosis hyperprolactinemia fertility treatment |
Who may qualify
- Ages
- 18 months to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women with normal and distrubed menstrual cycles Women receiving fertility treatment
Key inclusion criteria (1 listed)
- Women during their reproductive phase, no hormonal therapy
Key exclusion criteria (1 listed)
- Amenorrhoae
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 |
|---|---|---|
| Fertility treatmentFertility treatment | Other | Normal, pathological cycle, infertility |
Primary outcome
Hormonal parameters
Time frame: 3 years
Development of a mathematical model of the menstrual cycle
1 secondary outcome
Dynamics of fertility treatment
Time frame: 2 years
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 7 Sep 2016.
- Derived from this study: PubMed 31244718Leeners B, Kruger THC, Geraedts K, Tronci E, Mancini T, Egli M, Roblitz S, Saleh L, Spanaus K, Schippert C, Zhang Y, Ille F. Associations Between Natural Physiological and Supraphysiological Estradiol Levels and Stress Perception. Front Psychol. 2019 Jun 11;10:1296. doi: 10.3389/fpsyg.2019.01296. eCollection 2019.
- 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. This study is not recruiting at the moment.
Brigitte Leeners, MD principal investigator
University Hospital Zurich, Division of Reproductive Endocrinology
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 Polycystic Ovary Syndrome and Endometriosis, run by University of Zurich at 1 site in Switzerland.
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 1 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 7 Sep 2016. 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 Switzerland. 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?
Hormonal parameters (time frame: 3 years). 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 NCT02098668, which also lists 1 linked publication.
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 7 Sep 2016.