Serum Biomarker HE4 During IVF Treatment

IVF Treatment Clinical Trial

— FHE4  

Official title:

Serum Concentration of HE4, a New Marker for Ovarian Cancer, Changes Little Throughout IVF Stimulation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01576744
• Other study ID #: FHE4-2010
• Status: Active, not recruiting
• Phase: N/A
• First received: April 10, 2012
• Last updated: June 1, 2012
• Start date: March 2010

Study information

• Verified date: June 2012
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 27 Years to 39 Years

Eligibility

Inclusion Criteria:

• infertility treated by IVF

Exclusion Criteria:

• pelvic tumor

• overweight (BMI over 35)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Human Epididymal Secretory Protein E4
• IVF Treatment

Locations

Country	Name	City	State
Finland	Department of Obstetrics and Gynecology, Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland,