NCT01576744

Brief Summary

Human epididymal secretory protein 4 (HE4) is a new biomarker for ovarian cancer. The effect of IVF stimulation will be evaluated in order to see whether severe hormonal changes in the gonadotrophin and steroid status affect the serum levels of this marker. Findings will be compared to serum concentrations of CA-125, which is currently the most often used marker for ovarian cancer. The intention is to determine the serum concentration of HE4 and CA-125 in serial samples in 20 women undergoing IVF stimulation. Samples will be taken following GnRH agonist suppression, 2-3 times during FSH stimulation, at ovum pick up and two weeks following embryo transfer at the time of the hCG-test. The ovarian follicle count and the serum estradiol concentrations are recorded throughout the treatment. The serum biomarker HE4 is expected to ba a stable marker, which does not respond significantly to hormonal stimulation.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Last Updated

June 4, 2012

Status Verified

June 1, 2012

Enrollment Period

2.3 years

First QC Date

April 10, 2012

Last Update Submit

June 1, 2012

Conditions

IVF TreatmentHuman Epididymal Secretory Protein E4

Keywords

HE4IVFBiomarkerOvarian cancerInfertility

Eligibility Criteria

Age27 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Finnish caucasian women being treated for infertility by in vitro-fertilization

You may qualify if:

  • infertility treated by IVF

You may not qualify if:

  • pelvic tumor
  • overweight (BMI over 35)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Turku University Hospital

Turku, 20520, Finland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Repeated serum samples

MeSH Terms

Conditions

Ovarian NeoplasmsInfertility

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Antti H Perheentupa, MD, PhD

    Department of Obstetrics and Gynecology, Turku University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 10, 2012

First Posted

April 12, 2012

Study Start

March 1, 2010

Primary Completion

June 1, 2012

Last Updated

June 4, 2012

Record last verified: 2012-06

Locations

FI(1)