A Single Centre Open-label Randomised Controlled Trial of Long Term Pituitary Down-regulation Before in Vitro Fertilisation for Women With Endometriosis: a Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Live birth rate
研究概览
简要总结
Endometriosis is a hormone dependent disease of women, in which endometrial tissue (the cells which line the uterus or womb) are found outside the uterus (womb). Some women with endometriosis may be infertile. However, treatments for infertility such as in vitro fertilization (IVF) or IVF with intracytoplasmic sperm injection (IVF-ICSI) appear to be less successful, i.e. the pregnancy rates are lower, for women with endometriosis than for women who may be infertile for other reasons.
Since endometriosis is hormone dependent, it has been suggested that suppressing the activity of hormones produced by the ovaries (which affect endometrial growth) may inactivate endometriosis and so increase the chances of pregnancy. Recently it has been proposed that taking the oral contraceptive pill (OCP) for 6 to 8 weeks before IVF or IVF-ICSI treatment could be used for this purpose.
For our study, which is a randomised controlled trial, women with endometriosis meeting the study criteria planning to undergo IVF or IVF-ICSI at the Oxford Fertility Unit will be recruited. Study participants will be randomised into 2 arms: experimental group and control group. The experimental group will be instructed to complete an 8 week course of OCP before beginning standard IVF treatment. The control group do not take any study medication before beginning standard IVF treatment. The IVF or IVF-ICSI treatment for both groups is not altered by participation in the study.
The aim of the study will be to determine if pretreatment with OCP improves IVF or IVF-ICSI success rates, such as live birth and pregnancy rates, in patients who suffer from endometriosis. The study is funded by the Oxford Fertility Unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Female aged 18 to 39 years old.
- •Intending to undergo treatment with a first, second or third cycle of IVF or IVF-ICSI.
- •Diagnosed with any degree of endometriosis or endometrioma.
- •Participants must meet World Health Organisation Group 1 or 2 eligibility requirements for Combined Oral Contraceptive use.
排除标准
- •The participant does not understand the English language, or has special communication needs. This is because it is impractical to provide, for this small scale study, information sheets and consent forms in other languages except English.
- •The patient has already undergone 3 or more IVF or IVF-ICSI cycles.
- •Patients who are already taking any medication to treat endometriosis such as progestins, OCP, Gonadotrophin Releasing Hormone agonists, danazol, mirena, etc. or who have done so within the last 3 months.
- •Participants who do not meet World Health Organisation Group 1 or 2 eligibility requirements for Combined Oral Contraceptive use.
研究组 & 干预措施
Group 1 OCP
Combined oral contraceptive pill (OCP) (Microgynon 30) containing Levonorgestrel/Ethinylestradiol 150/30mcg. Taken orally on a continuous regime for 8 weeks, once a day.
干预措施: Combined Oral Contraceptive Pill (Microgynon 30) (Drug)
结局指标
主要结局
Live birth rate
时间窗: up to 40 weeks following embryo transfer date
The birth of a live child after 24 gestational weeks
次要结局
- Number of ectopic pregnancies(up to 6 weeks after embryo transfer)
- Multiple pregnancy rate(Up to 6 weeks after final embryo transfer)
- IVF Cycle outcomes(up to 40 weeks following embryo transfer date)
- Treatment responses per cycle(up to one week after egg collection)
- Number of cases of Ovarian Hyperstimulation Syndrome(Up to 4 weeks after final embryo transfer)