Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04426760
Study type Observational [Patient Registry]
Source Oslo University Hospital
Contact Thea F. Mikkelsen, MD
Phone 004797612934
Email themik@ous-hf.no
Status Recruiting
Phase
Start date March 1, 2019
Completion date September 15, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04519593 - ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma N/A
Recruiting NCT04935333 - Accuracy of the Preoperative Molecular Diagnosis of Uterine Tumors by Liquid Biopsy
Recruiting NCT05409872 - Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids N/A
Recruiting NCT05517590 - Intravenous Tranexamic Acid and Intramyometrial Desmopressin Effect on Blood Loss During Laparoscopic Myomectomy. N/A
Recruiting NCT05607602 - Are Uterine Fibroids Pro-thrombotic?
Recruiting NCT04004884 - Liver Safety Assessment During Ulipristal Acetate Treatment for Uterine Fibroids (LISA)
Not yet recruiting NCT06143631 - Prescription of Letrozole for Uterine Myoma Phase 4
Recruiting NCT05518812 - Carboprost (Hemabate) for Fibroid Resection Early Phase 1
Recruiting NCT05364008 - FRIEND: Fibroids and Unexplained Infertility Treatment With Epigallocatechin Gallate; A Natural CompounD in Green Tea Phase 3
Recruiting NCT05500118 - Establishment of a Decision Aid Tool for Asymptomatic Small Leiomyoma and Analysis of Influencing Factors for Clinical Decision-making Using HIFU
Recruiting NCT03400826 - Effects of Simvastatin on Uterine Leiomyoma Size Phase 2