Auto-transplantation of Fragmented Ovarian Cortical Tissue in Infertile Patients With Premature Ovarian Oocyte Depletion - a Study to Promote Follicular Activation and Subsequent Fertility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of follicles > 12 mm
研究概览
简要总结
The aim of this project is to activate recruitment and growth of resting primordial follicles in the ovaries of women with diminished ovarian reserve, in attempt to increase the chance to become pregnant, either naturally or after assisted reproduction.
详细描述
For this study investigators will carefully select 20 women with low AMH and imminent POI.
They will be randomized to have cortical ovarian biopsies taken from either the left or right ovary. The biopsies will be fragmented in 1x1 mm2 pieces and immediately auto-transplanted in a peritoneal pocket under the right ovary.
The contralateral untouched ovary will act as the control, making each woman their own control.
Follow up: each week in 2,5 months the women will be assessed by transvaginal ultrasound and hormonal status. After 2,5-6 months the women will receive a FSH stimulation cycle (rFSH 300 IU or Corifollitropin) followed by standard IVF/ICSI,
Hypothesis
the ovaries contain a pool of resting primordial follicles. By fragmentation of cortical ovarian tissue, manipulation of the local environment in the tissue will inhibit the Hippo Pathway and hereby active recruitment and growth of primordial follicles.
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 (Investigator)
入排标准
- 年龄范围
- 25 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertility with indication for IVF/ICSI
- •Imminent POI, still cycling
- •Age 25 - 39 years
- •Two ovaries
- •Serum AMH measurements < 5 pmol/l (two independent measurements)
- •Antral follicle count (AFC) (sum of both ovaries < 5)
排除标准
- •Ovarian pathology (endometriosis, cysts)
- •Known chromosomal abnormality
- •Known autoimmune disease (except TPO-antibodies)
- •Patients who have contraindication for laparoscopy
结局指标
主要结局
Number of follicles > 12 mm
时间窗: Up to 6 month after the auto-transplantation
Number of follicles \> 12 mm in response to controlled ovarian stimulation with corifollitropin from the biopsied ovary versus the contralateral untreated ovary
次要结局
- Side of ovulation(Up to 6 months after auto-transplantation)
研究者
Anders Nyboe Andersen
Professor M.D.
Rigshospitalet, Denmark