Mechanical Stimulation of the Ovary for Infertility Treatment in Patients With Very Low Ovarian Reserve
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 主要终点
- FSH levels
研究概览
简要总结
Examine the possibility that mechanical stimulation and ovarian fragmentation in women with premature ovarian failure or low ovarian reserve intended for egg donation may cause early follicular recruitment and increase chances of achieving pregnancy through IVF.
详细描述
The women will undergo a surgical laparoscopy during which one of the two technique will ensue.
- One of the ovaries will be scratched ( 2 mm depth) with a knife. Simultaneously, a piece of the ovary will be preserved for further histologic analysis and research in the laboratory.
- A piece of one ovary will be resected (up to one third of the ovary's volume, without harming the other ovary.
The resected ovarian tissue will be transferred immediately to the laboratory where the cortex will be divided from the medulla and sliced to small pieces of 1-2 square millimeters.
These pieces will be transferred back to the operation room in order for them to be transplanted under the serosa layer of the remaining ovary.
Any bleeding would be stopped using a stiches or hemostatic mesh (diathermy will not be used).
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
- 21 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women, aged 21-
- •with premature ovarian failure.
- •Healthy women, with poor ovarian reserve, aged 38-45, undergoing IVF Low ovarian response: recruitment of up to three eggs in previous treatments.
- •After the failure of at least 4 cycles.
- •Two functioning ovaries, follicular and hormonal response of both ovaries in prior therapies.
- •Women candidates for egg donation, and seeking further treatment before switching to egg donation.
排除标准
- •Women with kidney disease.
- •Women with infertility factors other than ovarian failure, such as endometriosis, PCOS, male factor.
- •Women with one non-functioning ovary, or that was removed.
- •Women with an intrauterine or pelvic pathology.
结局指标
主要结局
FSH levels
时间窗: 2 years
FSH levels at. day 2-3 of menstruation IU/L
Antral follicular count
时间窗: 2 years
measurement of. any antral follicles at day 3-5 with ultrasound
IVF outcomes fertilization rates
时间窗: 2 years
fertilization rate. - number of fertilized oocytes relatively to total number of oocytes
Menstrual cycle surveillance
时间窗: 2 years
Duration of the menstrual period (days)
AMH
时间窗: 2 years
Ovarian reserve measurements. AMH levels ng/ml
Estradiol
时间窗: 2 years
Estradiol levels at day of HCG in Pmol/L
IVF outcomes
时间窗: 2 years
Number of oocytes at OPU
次要结局
未报告次要终点