Mathematical Model for the Human Menstrual Cycle, Endocri... | NCT02098668

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

NCT02098668

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Sep 7, 2016Estimated

Enrollment

123Actual

Phase

Not provided

Conditions

Polycystic Ovary Syndrome
Endometriosis
Hyperprolactinemia

Interventions

Fertility treatment

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Feb 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Jun 18, 2013

First Submission Date that Met QC Criteria

Mar 25, 2014

First Posted Date

Mar 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2016

Last Update Posted Date

Sep 7, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

123Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal, pathological cycle, infertility		healthy women PCOS Endometriosis hyperprolactinemia fertility treatment	Other: Fertility treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fertility treatment	Other	Fertility treatment	Normal, pathological cycle, infertility

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hormonal parameters	Development of a mathematical model of the menstrual cycle	3 years

Secondary Outcomes

Measure	Description	Time Frame
Dynamics of fertility treatment	Mathematical model to improve fertility treatments	2 years

Other Outcomes

Measure	Description	Time Frame
Dynamics of gyneco-endocrinological diseases	To better understand the pathophysiological mechanisms in endocrinological diseases	3 years

Eligibility Module

Eligibility Criteria

Inclusion criteria:

- Women during their reproductive phase, no hormonal therapy

Exclusion criteria:

- Amenorrhoae

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Months

Maximum Age

43 Years

Standard Ages

ChildAdult

Study Population

Women with normal and distrubed menstrual cycles Women receiving fertility treatment

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brigitte Leeners, MD	University Hospital Zurich, Division of Reproductive Endocrinology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich, Division of Reproductive Endocrinology		Zurich	Canton of Zurich	8091	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31244718	Derived	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.

ID	Term
D011085	Polycystic Ovary Syndrome
D004715	Endometriosis
D006966	Hyperprolactinemia
D007246	Infertility

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291