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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02098668
First Posted: March 28, 2014
Last Update Posted: September 7, 2016
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.
Information provided by (Responsible Party):
University of Zurich
  Purpose
Development of a bio-mathematical model of the human female cycle

Condition Intervention
Polycystic Ovary Syndrome Endometriosis Hyperprolactinemia Other: Fertility treatment

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Model Driven Computation for Infertility Related Endocrinological Diseases - PAEON

Resource links provided by NLM:


Further study details as provided by University of Zurich:

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


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


Other Outcome Measures:
  • 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

Enrollment: 123
Study Start Date: September 2013
Study Completion Date: April 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Normal, pathological cycle, infertility
healthy women PCOS Endometriosis hyperprolactinemia fertility treatment
Other: Fertility treatment
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.
  Eligibility

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
Criteria

Inclusion criteria:

- Women during their reproductive phase, no hormonal therapy

Exclusion criteria:

- Amenorrhoae

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02098668


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

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02098668     History of Changes
Other Study ID Numbers: 17721_PAEON
First Submitted: June 18, 2013
First Posted: March 28, 2014
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
PCOS
hyperprolactinemia
endometriosis
infertility

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Endometriosis
Hyperprolactinemia
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases