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Serum Biomarker HE4 During IVF Treatment (FHE4)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Antti Perheentupa, Turku University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01576744
First Posted: April 12, 2012
Last Update Posted: June 4, 2012
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.
Information provided by (Responsible Party):
Antti Perheentupa, Turku University Hospital
  Purpose

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
IVF Treatment Human Epididymal Secretory Protein E4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Serum Concentration of HE4, a New Marker for Ovarian Cancer, Changes Little Throughout IVF Stimulation

Resource links provided by NLM:


Further study details as provided by Antti Perheentupa, Turku University Hospital:

Biospecimen Retention:   Samples Without DNA
Repeated serum samples

Enrollment: 20
Study Start Date: March 2010
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
  Eligibility

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
Criteria

Inclusion Criteria:

  • infertility treated by IVF

Exclusion Criteria:

  • pelvic tumor
  • overweight (BMI over 35)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01576744


Locations
Finland
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
  More Information

Responsible Party: Antti Perheentupa, Associate Professor, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01576744     History of Changes
Other Study ID Numbers: FHE4-2010
First Submitted: April 10, 2012
First Posted: April 12, 2012
Last Update Posted: June 4, 2012
Last Verified: June 2012

Keywords provided by Antti Perheentupa, Turku University Hospital:
HE4
IVF
Biomarker
Ovarian cancer
Infertility