Serum Biomarker HE4 During IVF Treatment (FHE4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01576744
Recruitment Status : Unknown
Verified June 2012 by Antti Perheentupa, Turku University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 12, 2012
Last Update Posted : June 4, 2012
Information provided by (Responsible Party):
Antti Perheentupa, Turku University Hospital

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
IVF Treatment Human Epididymal Secretory Protein E4

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 : March 2010
Estimated Primary Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Biospecimen Retention:   Samples Without DNA
Repeated serum samples

Information from the National Library of Medicine

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Ages Eligible for Study:   27 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Finnish caucasian women being treated for infertility by in vitro-fertilization

Inclusion Criteria:

  • infertility treated by IVF

Exclusion Criteria:

  • pelvic tumor
  • overweight (BMI over 35)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01576744

Department of Obstetrics and Gynecology, Turku University Hospital
Turku, Finland, 20520
Sponsors and Collaborators
Turku University Hospital
Principal Investigator: Antti H Perheentupa, MD, PhD Department of Obstetrics and Gynecology, Turku University Hospital

Responsible Party: Antti Perheentupa, Associate Professor, Turku University Hospital Identifier: NCT01576744     History of Changes
Other Study ID Numbers: FHE4-2010
First Posted: April 12, 2012    Key Record Dates
Last Update Posted: June 4, 2012
Last Verified: June 2012

Keywords provided by Antti Perheentupa, Turku University Hospital:
Ovarian cancer