Status:
UNKNOWN
Fibroids and Infertility - a Study of the Significance of Removal of Fibroids With Regard to Endometrial Receptivity
Lead Sponsor:
Oslo University Hospital
Conditions:
Leiomyoma, Uterine
Eligibility:
FEMALE
18-40 years
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 endometri...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 15 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04426760
Start Date
March 1 2019
End Date
September 15 2024
Last Update
June 11 2020
Active Locations (1)
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1
Oslo University Hospital
Oslo, Norway