Serum Biomarker HE4 During IVF Treatment (FHE4)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Turku University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Antti Perheentupa, Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01576744
First received: April 10, 2012
Last updated: June 1, 2012
Last verified: June 2012
  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 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

Ages Eligible for Study:   27 Years to 39 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Antti Perheentupa, Associate Professor, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01576744     History of Changes
Other Study ID Numbers: FHE4-2010
Study First Received: April 10, 2012
Last Updated: June 1, 2012
Health Authority: Finland: Ethics Committee

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

ClinicalTrials.gov processed this record on October 19, 2014