NCT02098668

Brief Summary

Development of a bio-mathematical model of the human female cycle

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 28, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

2.4 years

First QC Date

June 18, 2013

Last Update Submit

September 6, 2016

Conditions

Polycystic Ovary SyndromeEndometriosisHyperprolactinemia

Keywords

menstrual cycle dynamicsPCOShyperprolactinemiaendometriosisinfertility

Outcome Measures

Primary Outcomes (1)

  • Hormonal parameters

    Development of a mathematical model of the menstrual cycle

    3 years

Secondary Outcomes (1)

  • Dynamics of fertility treatment

    2 years

Other Outcomes (1)

  • Dynamics of gyneco-endocrinological diseases

    3 years

Study Arms (1)

Normal, pathological cycle, infertility

healthy women PCOS Endometriosis hyperprolactinemia fertility treatment

Other: Fertility treatment

Interventions

Fertility treatmentOTHER

Fertility treatment

Normal, pathological cycle, infertility

Eligibility Criteria

Age18 Months - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Women with normal and distrubed menstrual cycles Women receiving fertility treatment

You may qualify if:

  • \- Women during their reproductive phase, no hormonal therapy

You may not qualify if:

  • \- Amenorrhoae

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Division of Reproductive Endocrinology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 31244718DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Probes to determine hormonal parameters

MeSH Terms

Conditions

Polycystic Ovary SyndromeEndometriosisHyperprolactinemiaInfertility

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Brigitte Leeners, MD

    University Hospital Zurich, Division of Reproductive Endocrinology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2013

First Posted

March 28, 2014

Study Start

September 1, 2013

Primary Completion

February 1, 2016

Study Completion

April 1, 2016

Last Updated

September 7, 2016

Record last verified: 2016-09

Locations

CH(1)