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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT02098668
First received: June 18, 2013
Last updated: March 25, 2014
Last verified: March 2014
  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 ] [ Designated as safety issue: No ]
    Development of a mathematical model of the menstrual cycle


Secondary Outcome Measures:
  • Dynamics of fertility treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Mathematical model to improve fertility treatments


Other Outcome Measures:
  • Dynamics of gyneco-endocrinological diseases [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    To better understand the pathophysiological mechanisms in endocrinological diseases


Biospecimen Retention:   Samples Without DNA

Probes to determine hormonal parameters


Estimated Enrollment: 110
Study Start Date: September 2013
Estimated Study Completion Date: February 2016
Estimated 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

Ages Eligible for Study:   18 Months to 43 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02098668

Contacts
Contact: Brigitte Leeners, MD brigitte.leeners@usz.ch

Locations
Switzerland
University Hospital Zurich, Division of Reproductive Endocrinology Recruiting
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

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02098668     History of Changes
Other Study ID Numbers: 17721_PAEON
Study First Received: June 18, 2013
Last Updated: March 25, 2014
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on September 18, 2014