Spots Global Cancer Trial Database for Fibroids and Infertility - a Study of the Significance of Removal of Fibroids With Regard to Endometrial Receptivity

Study Description

Brief Summary: We aim to explore some of the molecular factors that reduce fertility for women with leiomyomas, taking into account leiomyoma location, size, number and vascularity. Tissue samples from the endometrium and leiomyomas will be obtained during the mid secretory phase before and 3-6 months after surgical excision for a comprehensive search for key molecular derangements.

Detailed Description: Baseline medical information and standard questionnaire to record symptoms are collected from all participants and a gynaecological examination and a 2D and 3D vaginal ultrasonography including saline infusion sonography (SIS), if indicated, are performed. Blood samples for the biobank for extraction of germ line DNA and for identification of possible biomarkers are taken. The women with submucosal leiomyomas will undergo hysteroscopic myomectomy and the women with intramural leiomyomas will undergo myomectomy per laparoscopy or laparotomy. For the participants with intramural leiomyomas and the fertile/infertile controls, endometrial samples are taken with an endometrial suction curette in an outpatient setting at day 19-23 of the menstrual cycle. The endometrial sampling in the group of women with submucosal leiomyomas is being done during the hysteroscopic removal of the leiomyoma, also at day 19-23 of the menstrual cycle. 3-6 months after surgery, cycle day 19-23, endometrial samples will be taken from the women who have undergone myomectomy and ultrasound examination is being performed. The women with submucosal leiomyomas will undergo a second look hysteroscopy

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

Contact Details

Useful links and downloads for this trial