An observational study in Leiomyoma, Uterine, sponsored by Oslo University Hospital. Status unknown at 1 site in Norway. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-11.
Sponsored by Oslo University Hospital · Observational
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.
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
490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.
This study's planned enrollment of 80 is below the median of 150 across 119 observational studies indexed under Leiomyoma.
Browse Leiomyoma studies →Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients referred to the Department of Gynaecology at Oslo University Hospital for treatment of submucosal or intramural leiomyomas.
Exclusion Criteria:
Women with submucosal leimyomas undergoing hysteroscopical removal of the leiomyoma
Procedure: Transcervical resection of fibroids
Women with intramural leiomyomas undergoing myomectomy
Procedure: Myomectomy per laparoscopy or laparotomy
Patients treated at the Department for Reproductive Medicine at the Oslo University hospital failing to conceive after 3 or more embryo transfers with good quality embryos.
Healthy, volunteering women with proved fertility with 1 or more deliveries and no history of infertility
Transcervical resection of fibroids
Myomectomy per laparoscopy or laparotomy
HOXA 10 expression
Fold change of HOXA 10 Expression 3-6 months after myomectomy compared to pre-surgery Levels
Time frame: 3-6 months
Expression of other molecular markers
Fold change of other molecular markers than HOXA 10 of endometrial receptivity 3-6 months after myomectomy and compared to fertile/infertile controls
Time frame: 3-6 months
Endometrial vascular pattern
VI and FI of the endometrium and subendometrial myometrium of women with leimyomas 3-6 months after myomectomy and compared to fertile/infertile controls
Time frame: 3-6 months
Vascular characteristics of leiomyomas
Vascular characteristics of leiomyomas associated with endometrial changes
Time frame: 3-6 months
Leiomyoma size
Leiomyomas size in centimeters associated with endometrial changes
Time frame: 3-6 months
Leiomyoma location
Leiomyoma location associated with endometrial changes
Time frame: 3-6 months
Genomic characteristics
Genomic characteristics of leiomyomas associated with endometrial changes
Time frame: 3-6 months
Scar formation
Scar/fibrosis/adhesion formation after myomectomy; macroscopically and histologically
Time frame: 3-6 months
Pregnancy
Pregnancy and deliveries within 2 years after myomectomy.
Time frame: 2 years
HOXA10 in endometrium of women with leiomyomas compared to fertile/infertile controls
Difference in HOXA 10 expression in endometrium of women with leiomyomas compared to fertile/infertile controls
Time frame: 3-6 months
Expression of molecular markers adjacent to the leiomyoma versus remote from the leiomyoma
Difference in expression of molecular markers in endometrium adjacent to the leiomyoma compared to endometrium remote from the leiomyoma.
Time frame: 3-6 months
Partially resected leiomyomas
Alterations in molecular markers of endometrial receptivity after partially resected submucosal leiomyomas.
Time frame: 3-6 months
Submucosal leiomyomas versus intramural leiomyomas
Difference in expression of molecular markers in endometrium of women with submucosal leiomyomas compared with endometrium in women with intramural leiomyomas.
Time frame: 3-6 months
Biomarkers in blood
Biomarkers in blood related to leiomyomas and a possible correlation between certain biomarkers and reduced endometrial receptivity.
Time frame: 1 year
This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Oslo University Hospital