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

NCT ID: NCT04426760

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2024-09-15

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

Conditions

Leiomyoma, Uterine

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Women with submucosal leiomyoma(s)

Women with submucosal leimyomas undergoing hysteroscopical removal of the leiomyoma

Transcervical resection of fibroids

Intervention Type: PROCEDURE

Transcervical resection of fibroids

Women with intramural leiomyomas

Women with intramural leiomyomas undergoing myomectomy

Myomectomy per laparoscopy or laparotomy

Intervention Type: PROCEDURE

Myomectomy per laparoscopy or laparotomy

Infertility patients

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.

No interventions assigned to this group

Fertile women

Healthy, volunteering women with proved fertility with 1 or more deliveries and no history of infertility

No interventions assigned to this group

Interventions

Transcervical resection of fibroids

Transcervical resection of fibroids

Intervention Type: PROCEDURE

Myomectomy per laparoscopy or laparotomy

Myomectomy per laparoscopy or laparotomy

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kirsten Hald, MD, PhD

Senior Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oslo University Hospital

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Thea F. Mikkelsen, MD

Role: CONTACT

themik@ous-hf.no

004797612934

Kirsten Hald, PhD

Role: CONTACT

UXKILD@ous-hf.no

004795224181

Facility Contacts

Thea F Mikkelsen, MD

Role: primary

themik@ous-hf.no

004797612934

Kirsten Hald, PhD

Role: backup

UXKILD@ous-hf.no

004795224181

Other Identifiers

2017/9703

Identifier Type: -

Identifier Source: org_study_id