Fibroids and Infertility - a Study of the Significance of Removal of Fibroids With Regard to Endometrial Receptivity

Leiomyoma, Uterine Clinical Trial

— FIN  

Official title:

Mechanisms of Reduced Fertility in Women With Uterine Leiomyomas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04426760
• Other study ID #: 2017/9703
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: September 15, 2024

Study information

• Verified date: June 2020
• Source: Oslo University Hospital
• Contact: Thea F. Mikkelsen, MD
• Phone: 004797612934
• Email: themik[@]ous-hf.no
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 15, 2024
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Leiomyoma, Uterine

Intervention

Procedure:
• Transcervical resection of fibroids
Transcervical resection of fibroids
• Myomectomy per laparoscopy or laparotomy
Myomectomy per laparoscopy or laparotomy

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HOXA 10 expression	Fold change of HOXA 10 Expression 3-6 months after myomectomy compared to pre-surgery Levels	3-6 months
Secondary	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	3-6 months
Secondary	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	3-6 months
Secondary	Vascular characteristics of leiomyomas	Vascular characteristics of leiomyomas associated with endometrial changes	3-6 months
Secondary	Leiomyoma size	Leiomyomas size in centimeters associated with endometrial changes	3-6 months
Secondary	Leiomyoma location	Leiomyoma location associated with endometrial changes	3-6 months
Secondary	Genomic characteristics	Genomic characteristics of leiomyomas associated with endometrial changes	3-6 months
Secondary	Scar formation	Scar/fibrosis/adhesion formation after myomectomy; macroscopically and histologically	3-6 months
Secondary	Pregnancy	Pregnancy and deliveries within 2 years after myomectomy.	2 years
Secondary	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	3-6 months
Secondary	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.	3-6 months
Secondary	Partially resected leiomyomas	Alterations in molecular markers of endometrial receptivity after partially resected submucosal leiomyomas.	3-6 months
Secondary	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.	3-6 months
Secondary	Biomarkers in blood	Biomarkers in blood related to leiomyomas and a possible correlation between certain biomarkers and reduced endometrial receptivity.	1 year