Randomised ,Blind, Placebo Controlled in Meir Center. Study the Potential of Reflexology Treatments to Help Implant Pregnancy in Ivf Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 主要终点
- number of pregnant women in women treated with implantation in IVF
研究概览
简要总结
Infertility is expressed as an inability to conceive or carry a healthy pregnancy to the end. It is often said that the couple suffers from infertility if for a year they could not get a normal pregnancy. 30% of the reasons for this unsuccess are attributed to women, 30% are attributed to men, while the other 40% of cases are attributed to the combination between men and women and for unknown reasons. In women, the source of most of the problems of infertility are associated with different failures in ovulation (early ovulation, lack of ovulation or irregular ovulation). Other reasons are Blocked fallopian tubes (due to endometriosis, infection or surgery), problems in the uterus and endometrium. There is a group of women that apparently does not have the failures described above, and they have infertility that does not include pathological findings. Apparently chronic stress is a potential cause among couples who could not get pregnant (despite 6 months of focused sex) so there is a request for various techniques for reducing stress including yoga and meditation. One common option in various conditions of infertility is in vitro fertilization. This technique is also known as artificial insemination and is the most common technique used in Israel. Data from the Ministry of Health from the last years, indicate that the rate of successful pregnancies after embryo transfer is more than a third (in average), this is from an average of 20 treatment cycles.
Researches in alternative medicine are not easy to carry out. The placebo group which is usually the control group tend to be a treatment group by itself and gives effective results than a group that does not receive treatment at all. Carrying out a strict study with a good control group such as reflexology research in multiple sclerosis, has brought significant results in various statistical measures examined in this study (movement, sensory mode and urinary tract symptoms).
In the control group the calf was chosen as a place of a massage as a dummy treatment (gynecological place), which prevented contact with specific points of the feet like in patients in the treatment group. This study wishes to answer the research question: Does reflexology treatment increase the chances of pregnancy implantation in women without pathological findings that are treated with IVF. Other questions related to measures that could lead to the implant of pregnancy, are whether reflexology treatment affect the endometrial thickness, number of oocytes and embryo quality. Literature indicates the potential of reflexology treatment on ovulation induction (But requires a good control group and large sample size).
详细描述
The purpose of the study:
Does reflexology treatment increase the chance of pregnancy in women treated with IVF?
Research design:
To the Study will recruited women who come for IVF treatments.
Women who are fit to participate and give their consent, will be randomized to one of three treatment groups:
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 42 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women age 18 To 42
- •women who receive IVF treatment
- •The number of IVF cycles - up to 7 cycles
- •Signing an informed consent form.
- •patient is required to receive at least 4 reflexology treatments until the eggs implant.
- •Exclusion criteria:
- •Women under 18 or over 42
- •patients who had 7 cycles of IVF
排除标准
- 未提供
结局指标
主要结局
number of pregnant women in women treated with implantation in IVF
时间窗: 6 Months
Does reflexology treatment increase the number of pregnant women in women treated with implantation in IVF
次要结局
- endometrial thickness(6 months)
- number of oocytes(6 months)
- embryo quality(6 months)
