Clinical trial NCT04426760: Fibroids and Infertility - a Study of the Significance of Removal of Fibroids With Regard to Endometrial Receptivity
Official title: Mechanisms of Reduced Fertility in Women With Uterine Leiomyomas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Leiomyoma, Uterine
Keywords: Infertility
Endometrial receptivity
Leiomyoma
Fibroid
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to the Department of Gynaecology at Oslo University Hospital for treatment of submucosal or intramural leiomyomas.

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

Eligibility criteria: Inclusion Criteria:

* Age: 18 to 40 years
* Presence of leiomyoma(s)
* Regular menstrual cycle (28 +/- 7 days)
* Having had at least 2 normal menstrual cycles after ending the treatment if previously treated with GnRH analogue
* Signed informed consent

Exclusion Criteria:

* No treatment indication (no symptoms and/or no desire for fertility)
* Contraindication for surgery
* Known endometriosis
* Known PCOS
* Untreated hydrosalpinx
* Malignancy; gynaecological or other location
* Pre-malignant or malignant pap smear or endometrial biopsy
* Hormonal treatment including ulipristal acetat and levonorgestrel intrauterine device last three months before inclusion in the study
* Ongoing treatment with GnRH analogue
* Pregnancy last 3 months
* Ongoing lactation

Primary outcomes:
measure: HOXA 10 expression
timeFrame: 3-6 months
Secondary outcomes:
measure: Expression of other molecular markers
timeFrame: 3-6 months
measure: Endometrial vascular pattern
timeFrame: 3-6 months
measure: Vascular characteristics of leiomyomas
timeFrame: 3-6 months
measure: Leiomyoma size
timeFrame: 3-6 months
measure: Leiomyoma location
timeFrame: 3-6 months
measure: Genomic characteristics
timeFrame: 3-6 months
measure: Scar formation
timeFrame: 3-6 months
measure: Pregnancy
timeFrame: 2 years
measure: HOXA10 in endometrium of women with leiomyomas compared to fertile/infertile controls
timeFrame: 3-6 months
measure: Expression of molecular markers adjacent to the leiomyoma versus remote from the leiomyoma
timeFrame: 3-6 months
measure: Partially resected leiomyomas
timeFrame: 3-6 months
measure: Submucosal leiomyomas versus intramural leiomyomas
timeFrame: 3-6 months
measure: Biomarkers in blood
timeFrame: 1 year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References: