NCT04426760

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2024

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

2.5 years

First QC Date

June 8, 2020

Last Update Submit

June 8, 2020

Conditions

Leiomyoma, Uterine

Keywords

InfertilityEndometrial receptivityLeiomyomaFibroid

Outcome Measures

Primary Outcomes (1)

  • HOXA 10 expression

    Fold change of HOXA 10 Expression 3-6 months after myomectomy compared to pre-surgery Levels

    3-6 months

Secondary Outcomes (13)

  • Expression of other molecular markers

    3-6 months

  • Endometrial vascular pattern

    3-6 months

  • Vascular characteristics of leiomyomas

    3-6 months

  • Leiomyoma size

    3-6 months

  • Leiomyoma location

    3-6 months

  • +8 more secondary outcomes

Study Arms (4)

Women with submucosal leiomyoma(s)

Women with submucosal leimyomas undergoing hysteroscopical removal of the leiomyoma

Procedure: Transcervical resection of fibroids

Women with intramural leiomyomas

Women with intramural leiomyomas undergoing myomectomy

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.

Fertile women

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

Interventions

Transcervical resection of fibroidsPROCEDURE

Transcervical resection of fibroids

Women with submucosal leiomyoma(s)
Myomectomy per laparoscopy or laparotomyPROCEDURE

Myomectomy per laparoscopy or laparotomy

Women with intramural leiomyomas

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe biological sex must be female since we are studying a phenomenone occuring in the female genital tract.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to the Department of Gynaecology at Oslo University Hospital for treatment of submucosal or intramural leiomyomas.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Ongoing treatment with GnRH analogue
  • Pregnancy last 3 months
  • Ongoing lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Endometrial biopsies Leiomyoma biopsy Serum Plasma Blood cells

MeSH Terms

Conditions

LeiomyomaInfertility

Interventions

Laparotomy

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGenital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Thea F. Mikkelsen, MD

CONTACT

004797612934themik@ous-hf.no

Kirsten Hald, PhD

CONTACT

004795224181UXKILD@ous-hf.no

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant

Study Record Dates

First Submitted

June 8, 2020

First Posted

June 11, 2020

Study Start

March 1, 2019

Primary Completion

September 15, 2021

Study Completion

September 15, 2024

Last Updated

June 11, 2020

Record last verified: 2020-06

Locations

NO(1)