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

STATUS

Recruiting
participants needed

80
sponsor

Oslo University Hospital

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Updated on 19 February 2024

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laparoscopy

infertility

leiomyoma

uterine myomectomy

gonadotropin-releasing hormone agonist

laparotomy

myomectomy

lh-rh analogs

Summary

Show definitions

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

Details

Condition	UTERINE FIBROID
Age	18years - 40years
Treatment	Transcervical resection of fibroids, Myomectomy per laparoscopy or laparotomy
Clinical Study Identifier	NCT04426760
Sponsor	Oslo University Hospital
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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

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