Mechanisms of Reduced Fertility in Women With Uterine Leiomyomas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- HOXA 10 expression
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
HOXA 10 expression
时间窗: 3-6 months
Fold change of HOXA 10 Expression 3-6 months after myomectomy compared to pre-surgery Levels
次要结局
- Expression of other molecular markers(3-6 months)
- Endometrial vascular pattern(3-6 months)
- Leiomyoma location(3-6 months)
- Scar formation(3-6 months)
- Pregnancy(2 years)
- Expression of molecular markers adjacent to the leiomyoma versus remote from the leiomyoma(3-6 months)
- Vascular characteristics of leiomyomas(3-6 months)
- Genomic characteristics(3-6 months)
- HOXA10 in endometrium of women with leiomyomas compared to fertile/infertile controls(3-6 months)
- Leiomyoma size(3-6 months)
- Partially resected leiomyomas(3-6 months)
- Submucosal leiomyomas versus intramural leiomyomas(3-6 months)
- Biomarkers in blood(1 year)
研究者
Kirsten Hald, MD, PhD
Senior Consultant
Oslo University Hospital