Serum Biomarker HE4 During IVF Treatment

• Conditions: IVF Treatment; Human Epididymal Secretory Protein E4

• Registration Number: NCT01576744
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-10
• Study First Posted: 2012-04-12
• Status Verified: 2012-06
• Primary Completion: 2012-06
• Last Update Submitted: 2012-06-01
• Last Update Posted: 2012-06-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• infertility treated by IVF

Exclusion Criteria

• pelvic tumor
• overweight (BMI over 35)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Turku University Hospital; 🇫🇮 Turku, Finland