IVF Outcome Following Treatment With Ulipristal Acetate for Myomatous Uterus After at Least One IVF Failure
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 主要终点
- Ongoing pregnancy
研究概览
简要总结
Hypothesis:
After reviewing the relevant medical data the investigators assume that treating a woman with intramural fibroid not distorting the uterine cavity or mostly intramural with less than 50% submucosal component with Ulipristal Acetate (UPA) for a 13 weeks course would reduce the fibroid size and improve her chance for conceiving by IVF treatment.
Materials & Methods:
Study design: A proof of concept prospective not randomized study. The patients: About 20 women treated in the fertility and IVF unit after at least one IVF failure, with mostly intramural (IM) fibroid [class 2-5 by FIGO (International Federation of Gynecology and Obstetrics) classification system] in the size of >4 cm confirmed by Transvaginal ultrasound (TVUS) and diagnostic hysteroscopy.
After US examination and diagnostic hysteroscopy to ascertain suitability for this study, the investigators will offer a course of 13 weeks treatment with UPA 5 mg per day.
One month after cessation of treatment the investigators will perform another TVUS examination & diagnostic hysteroscopy plus endometrial biopsy in order to assess the endometrial & uterine status and will conduct an additional IVF cycle, using the same stimulation protocol undertaken during the immediate cycle previous to the UPA treatment course.
详细描述
Ulipristal Acetate - Study design
Introduction:
Leiomyomas are well established factors to affect fertility. The key factor for fertility disturbance is the fibroid location and not its size. The presence of submucosal fibroids has long been known to reduce fertility as opposed to subserosal fibroids which do not alter fertility. The effect of intramural fibroids on fertility is still a mystery.
These findings were best described in a meta-analysis of 23 studies:
- With no respect to location, women with fibroids have a lower chance for ongoing pregnancy or live birth (RR 0.7, 95% CI 0.59-0.83) and a greater chance for spontaneous abortion (RR 1.68, 95% CI 1.37-2.05).
- Women with fibroids that were submucosal or intramural with an intracavitary component were less likely to become pregnant (RR 0.36, 95% CI 0.18-0.74) and more likely to have a spontaneous abortion (RR 1.7, 95% CI 1.4-2.1).
- The picture is less clear for women with intramural fibroids. Overall, studies of women with fibroids that did not distort the uterine cavity were less likely to become pregnant (RR 0.81, 95% CI 0.70-0.94), less likely to have an ongoing pregnancy or to deliver a live newborn (RR 0.7, 95% CI 0.58-0.85) and more likely to have a spontaneous abortion (RR 1.7, 95% CI 1.2-2.5).
- In addition to these findings, women with cavity-distorting fibroids who undergone myomectomy had a significant increase in conception rate (RR 2.03, 95% CI 1.08-3.83).
- There were no significant differences between women who had myomectomy for intramural fibroids and those who did not go through surgical treatment, although the data for this issue is quite lame.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile women in the age of 18-44 years
- •At least after one failure in IVF treatment
- •Normal responders (more than 3 oocytes retrieved in previous controlled ovarian hyperstimulation treatment).
- •Intramural fibroid between 4-10 cm, not distorting the uterine cavity
排除标准
- •Intolerance for UPA treatment
- •Fibroids distorting the uterine cavity
- •Poor responder
研究组 & 干预措施
Ulipristal acetate treatment
Women who receive UPA treatment before another IVF cycle.
干预措施: Ulipristal acetate (Drug)
结局指标
主要结局
Ongoing pregnancy
时间窗: About 10-12 weeks after embryo transfer
Number of viable pregnancies at about 10-12 weeks of gestation
Clinical pregnancy
时间窗: 3 weeks after embryo transfer
Number of cases with gestational sac per US exam
次要结局
- Fibroids status(A month after the end of UPA treatment)
- Uterus size(A month after the end of UPA treatment)
- Number of oocytes retrieved(Right after ovarian pick-up)
- Number of embryos(About 3 days after OPU (ovum pick-up))
- Number of top quality embryos(3 days after OPU)
- Live birth(Until 40 weeks past embryo transfer)
研究者
Dr. Eran Zilberberg
Doctor, IVF unit
Sheba Medical Center