This trial is active, not recruiting.

Conditions ivf treatment, human epididymal secretory protein e4
Sponsor Turku University Hospital
Start date March 2010
End date June 2012
Trial size 20 participants
Trial identifier NCT01576744, FHE4-2010


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Eligibility Criteria

Female participants from 27 years up to 39 years old.

Inclusion Criteria: - infertility treated by IVF Exclusion Criteria: - pelvic tumor - overweight (BMI over 35)

Additional Information

Official title Serum Concentration of HE4, a New Marker for Ovarian Cancer, Changes Little Throughout IVF Stimulation
Principal investigator Antti H Perheentupa, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by Turku University Hospital.