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

Last updated: June 8, 2020
Sponsor: Oslo University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sarcoma (Pediatric)

Desmoid Tumors

Uterina Myoma

Treatment

N/A

Clinical Study ID

NCT04426760
2017/9703
  • Ages 18-40
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 previouslytreated with GnRH analogue

  • Signed informed consent

Exclusion

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 devicelast three months before inclusion in the study

  • Ongoing treatment with GnRH analogue

  • Pregnancy last 3 months

  • Ongoing lactation

Study Design

Total Participants: 80
Study Start date:
March 01, 2019
Estimated Completion Date:
September 15, 2024

Study 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

Connect with a study center

  • Oslo University Hospital

    Oslo,
    Norway

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.