Short summary

The primary objective of the PhD project is to examine the endometrial function in fertile women undergoing one of two regimens for treatment of uterine fibroids - either surgical removal (myomectomy) or occlusion of afferent vessels (embolization). The secondary objective is to study how the two regimens may change endocrine and ovarian reserve markers. Besides using conventional methods such as measurements of hormone levels, new promising methods including gene expression analyses and secretomics of the endometrium will be used to explore possible differences between the two regimens.

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Rationale

Background: Fibroids in the uterus occurs in about 30% of fertile women. Some fibroids affect female fertility. Current recommend surgically removing as first choice. Embolization treatment is a well-known, non-surgical alternative for women with no pregnancy desired. This method is less invasive compared to surgical removal and is associated with fewer complications and reduced recovery time. However, it has been reluctant to use the method for women with pregnancy desire. It is unknown whether the embolization affect the uterine mucosa and thereby the implantation.

Aim: Compare surgically removing of fibroids with embolization treatment, in respect to effects on fertility.

Method: The women will be examined before and after the 2 treatments. Women will undergo hysteroscopic examination of the uterus whereby the endometrium are visually examined and biopsies are taken. Secret from the cervix and uterus will be send for gene expression analysis. The project will place particular emphasis on gene expression. We have agreed cooperation with a leading international expert in the field; laboratory of Carlos Simon, Spain. In addition, the women get blood tests to measure hormone production and egg reserve and conducted MR scan.

Result: We expect embolization and surgical removal to be equivalent methods with respect to effects on fertility.

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Description of the cohort

Participants:

Experimental Population 1

Fertile women, who after assessment of the Obstetrics and Gynaecological Department, Odense University Hospital / Svendborg or the collaborating Hospital Nykoebing Falster, Denmark, are planned to undergo either myomectomy or embolization. A total of 40 patients have been planned to be enrolled during a 2-year period. Patients will be examined at baseline and 6 months after the intervention.

Patients will be divided and randomized into three groups:

1: Women undergoing myomectomy, 20 patients

2: Women undergoing embolization, 20 patients

Experimental Population 2 (reference group)

After examination at Dept. of Obstetrics and Gynaecology OUH/Svendborg or Nykoebing Falster Hospital, Denmark, fertile women who are endometrial healthy will be ask to participate. A total of 20 women will be included.

Data and biological material

Data from the journal- age, BMI, parity, previous gynecological diseases,medicine are collected.

At baseline and after 6 months a blood sample of 40 ml is drawn and plasma as well as the buffy coat are frozen at minus 20^oC for subsequent analyses, including analyses for AMH, FSH, LH, and estradiol. In addition, CRP, leukocytes will be measured in order to measure the inflammatory response.

Secretomics, samples from the endometrial fluid.

In all patients biopsies from the endometrium is taken using Endometrial hysteroscopy.

Collaborating researchers and departments

Department of Obstetrics and Gynaecology, Nykoebing Falsker Hospital

• Helge Gimbel, MD

Department of Obstetrics and Gynaecology, Valencia University, Spain

• Professor Carlos Simon

Endometrial Receptivity Department IGENOMIX, Spain

• Laboratory Manager Maria Ruiz Alons