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FHE4: Serum Biomarker HE4 During IVF Treatment

Sponsor
Turku University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01576744
Collaborator
(none)
20
Enrollment
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Serum Concentration of HE4, a New Marker for Ovarian Cancer, Changes Little Throughout IVF Stimulation
    Study Start Date :
    Mar 1, 2010
    Anticipated Primary Completion Date :
    Jun 1, 2012

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      27 Years to 39 Years
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • infertility treated by IVF
      Exclusion Criteria:

      • pelvic tumor

      • overweight (BMI over 35)

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Department of Obstetrics and Gynecology, Turku University Hospital Turku Finland 20520

      Sponsors and Collaborators

      • Turku University Hospital

      Investigators

      • Principal Investigator: Antti H Perheentupa, MD, PhD, Department of Obstetrics and Gynecology, Turku University Hospital

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Antti Perheentupa, Associate Professor, Turku University Hospital
      ClinicalTrials.gov Identifier:
      NCT01576744
      Other Study ID Numbers:
      • FHE4-2010
      First Posted:
      Apr 12, 2012
      Last Update Posted:
      Jun 4, 2012
      Last Verified:
      Jun 1, 2012
      Keywords provided by Antti Perheentupa, Associate Professor, Turku University Hospital
      HE4
      IVF
      Biomarker
      Ovarian cancer
      Infertility

      Study Results

      No Results Posted as of Jun 4, 2012