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Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON (PAEON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02098668
Recruitment Status : Completed
First Posted : March 28, 2014
Last Update Posted : September 7, 2016
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
Development of a bio-mathematical model of the human female cycle

Condition or disease Intervention/treatment
Polycystic Ovary Syndrome Endometriosis Hyperprolactinemia Other: Fertility treatment

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.

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Study Type : Observational
Actual Enrollment : 123 participants
Time Perspective: Prospective
Official Title: Model Driven Computation for Infertility Related Endocrinological Diseases - PAEON
Study Start Date : September 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : April 2016

Group/Cohort Intervention/treatment
Normal, pathological cycle, infertility
healthy women PCOS Endometriosis hyperprolactinemia fertility treatment
Other: Fertility treatment
Fertility treatment

Primary Outcome Measures :
  1. Hormonal parameters [ Time Frame: 3 years ]
    Development of a mathematical model of the menstrual cycle

Secondary Outcome Measures :
  1. Dynamics of fertility treatment [ Time Frame: 2 years ]
    Mathematical model to improve fertility treatments

Other Outcome Measures:
  1. Dynamics of gyneco-endocrinological diseases [ Time Frame: 3 years ]
    To better understand the pathophysiological mechanisms in endocrinological diseases

Biospecimen Retention:   Samples Without DNA
Probes to determine hormonal parameters

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 43 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women with normal and distrubed menstrual cycles Women receiving fertility treatment

Inclusion criteria:

- Women during their reproductive phase, no hormonal therapy

Exclusion criteria:

- Amenorrhoae

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02098668

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University Hospital Zurich, Division of Reproductive Endocrinology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
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Principal Investigator: Brigitte Leeners, MD University Hospital Zurich, Division of Reproductive Endocrinology

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Zurich Identifier: NCT02098668     History of Changes
Other Study ID Numbers: 17721_PAEON
First Posted: March 28, 2014    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Zurich:
menstrual cycle dynamics
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Genital Diseases, Female
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases